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1. Hydroxychloroquine and mortality in COVID-19 patients: a systematic review and a meta-analysis of observational studies and randomized controlled trials

Author

Simona Costanzo, Licia Iacoviello, Antonio Cassone, Roberto Cauda, Giovanni de Gaetano, and Augusto Di Castelnuovo

Subjects
0301 basic medicine, medicine.medical_specialty, hydroxychloroquine, Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, 030231 tropical medicine, 030106 microbiology, SARS-COV-2, Azithromycin, Antiviral Agents, Microbiology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, Humans, Adverse effect, Randomized Controlled Trials as Topic, business.industry, Public Health, Environmental and Occupational Health, COVID-19, Chloroquine, Hydroxychloroquine, General Medicine, mortality, COVID-19 Drug Treatment, Treatment Outcome, Infectious Diseases, Relative risk, Meta-analysis, Parasitology, Observational study, business, Research Article, Cohort study, medicine.drug
Abstract

Background: Hydroxychloroquine (HCQ) was proposed as potential treatment for COVID-19, but its association with mortality is unclear. We reviewed published literature for evidence of an association between HCQ (with or without azithromycin (AZM)) and total mortality in COVID-19 patients. Methods: Articles were retrieved until April 29th, 2021 by searching in seven databases. Data were combined using the general-variance-based method. Results: A total of 25 cohort studies (N=41,339 patients) and 11 randomized clinical trials (RCTs; N=8,709) were found. The use of HCQ was not associated with mortality in meta-analysis of RCTs (pooled risk ratio (PRR): 1.08, 95%CI: 0.97-1.20; I2=0%), but it was associated with 20% lower mortality risk (PRR=0.80, 95%CI: 0.69-0.93; I2=80%) in pooling of cohort studies. The negative association with mortality was mainly apparent by pooling cohort studies that used lower doses of HCQ (���400 mg/day; PRR=0.69, 95%CI: 0.57-0.87). Use of HCQ+AZM (11 studies) was associated with 25% non-statistically significant lower mortality risk (PPR=0.75; 0.51-1.10; P=0.15). Use of HCQ was not associated with severe adverse events (PRR=1.12, 95%CI: 0.88-1.44; I2=0%). Conclusions: HCQ use was not associated with mortality in COVID-19 patients in pooling results from RCTs (high level of certainty of evidence), but it was associated with 20% mortality reduction when findings from observational studies were combined (low level of certainty of evidence). The reduction of mortality was mainly apparent in observational studies where lower doses of HCQ were used. These findings might help disentangling the debate on HCQ use in COVID-19.

Published
2021

2. Multicomponent vaccines to fight SARS-CoV-2 variants of concern

Author

Antonio Cassone and Roberto Cauda

Subjects
Vaccines, 2019-20 coronavirus outbreak, General Veterinary, General Immunology and Microbiology, Coronavirus disease 2019 (COVID-19), Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, SARS-CoV-2, business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Public Health, Environmental and Occupational Health, COVID-19, Antibodies, Neutralizing, Virology, Nucleoprotein, Infectious Diseases, Commentary, Humans, Molecular Medicine, Medicine, business
Published
2021

3. White Paper: Bridging the gap between surveillance data and antimicrobial stewardship in the outpatient sector—practical guidance from the JPIAMR ARCH and COMBACTE-MAGNET EPI-Net networks

Author

Arieti, Fabiana, Göpel, Siri, Sibani, Marcella, Carrara, Elena, Pezzani, Maria Diletta, Murri, Rita, Mutters, Nico T, Lòpez-Cerero, Lorena, Voss, Andreas, Cauda, Roberto, Tacconelli, Evelina, ARCH working group (Collaborators): Ayola Akim Adegnika, Fabiana, Arieti, Nithya Babu Rajendran, Julia, Bielicki, Steffen, Borrmann, Elena, Carrara, Roberto, Cauda, Compri, Monica, Giulia De Angelis, Raquel, Duro, Galia, Liliana, Petra, Gastmeier, Christian, Giske, Siri, Göpel, Herman, Goossens, Gunnar, Kahlmeter, Souha, S Kanj, Tomislav, Kostyanev, Leonard, Leibovici, Jean-Christophe, Lucet, Lorena, López-Cerero, Rodolphe, Mader, Mazzaferri, Fulvia, Elena, Mazzolini, Marc, Mendelson, Rita, Murri, Nico, T Mutters, Mical, Paul, Maria Diletta Pezzani, Elisabeth, Presterl, Hanna, R Enk, Oana, Sandulescu, Le Huu Song, Remco, Schrijver, Luigia, Scudeller, Mike, Sharland, Marcella, Sibani, Evelina, Tacconelli, Didem, Torumkuney, Thirumalaisamy, P Velavan, and Andreas, Voss

Subjects
0301 basic medicine, Microbiology (medical), Knowledge management, ESSENTIAL MEDICINES LIST, ANTIBIOTIC STEWARDSHIP, GENERAL-PRACTICE, CARE, RESISTANCE, PRESCRIPTIONS, PRESCRIBERS, PROVISION, INVENTORY, FEEDBACK, Computer science, 030106 microbiology, Delphi method, INVENTORY, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, PRESCRIPTIONS, Antimicrobial Stewardship, 0302 clinical medicine, White paper, GENERAL-PRACTICE, Outpatients, Antimicrobial stewardship, AcademicSubjects/MED00740, Humans, Pharmacology (medical), 030212 general & internal medicine, PRESCRIBERS, Pharmacology, Team composition, Government, ESSENTIAL MEDICINES LIST, PROVISION, FEEDBACK, business.industry, CARE, ANTIBIOTIC STEWARDSHIP, Checklist, Hospitals, Anti-Bacterial Agents, Long-term care, Infectious Diseases, AcademicSubjects/MED00290, Supplement Papers, Accountability, Magnets, Antimicrobial, business, AcademicSubjects/MED00230, RESISTANCE
Abstract

Background The outpatient setting is a key scenario for the implementation of antimicrobial stewardship (AMS) activities, considering that overconsumption of antibiotics occurs mainly outside hospitals. This publication is the result of a joint initiative by the JPIAMR ARCH and COMBACTE-MAGNET EPI-Net networks, which is aimed at formulating a set of target actions for linking surveillance data with AMS activities in the outpatient setting. Methods A scoping review of the literature was carried out in three research areas: AMS leadership and accountability; antimicrobial usage and AMS; antimicrobial resistance and AMS. Consensus on the actions was reached through a RAND-modified Delphi process involving over 40 experts in infectious diseases, clinical microbiology, AMS, veterinary medicine or public health, from 18 low-, middle- and high-income countries. Results Evidence was retrieved from 38 documents, and an initial 25 target actions were proposed, differentiating between essential or desirable targets according to clinical relevance, feasibility and applicability to settings and resources. In the first consultation round, preliminary agreement was reached for all targets. Further to a second review, 6 statements were re-considered and 3 were deleted, leading to a final list of 22 target actions in the form of a practical checklist. Conclusions This White Paper is a pragmatic and flexible tool to guide the development of calibrated surveillance-based AMS interventions specific to the outpatient setting, which is characterized by substantial inter- and intra-country variability in the organization of healthcare structures, maintaining a global perspective and taking into account the feasibility of the target actions in low-resource settings.

Published
2020

4. Liability of Health Care Professionals and Institutions During COVID-19 Pandemic in Italy: Symposium Proceedings and Position Statement

Author

Giovanni Scambia, Roberto Cauda, Marco Marazza, Rocco Domenico Alfonso Bellantone, Matteo Caputo, G Vetrugno, Gabrio Forti, Simone Grassi, Vincenzo Lorenzo Pascali, Antonio Oliva, and Giulio Ponzanelli

Subjects
Coronavirus disease 2019 (COVID-19), Leadership and Management, Health Personnel, Legislation, Pneumonia, Viral, Psychological intervention, Settore MED/17 - MALATTIE INFETTIVE, Hospital, Betacoronavirus, 03 medical and health sciences, 0302 clinical medicine, Nursing, Liability, Malpractice, Health care, Pandemic, medical liability, Humans, Viral, 030212 general & internal medicine, Pandemics, Personal protective equipment, health care economics and organizations, SARS-CoV-2, business.industry, 030503 health policy & services, Public Health, Environmental and Occupational Health, COVID-19, Liability, Legal, Pneumonia, Original Articles, forensic pathology, humanities, pandemic medicolegal implications, Italy, Legislation, Hospital, Legal, Coronavirus Infections, 0305 other medical science, business, Gross negligence
Abstract

BACKGROUND: On May 12, 2020, a symposium titled "Liability of healthcare professionals and institutions during COVID-19 pandemic" was held in Italy with the participation of national experts in malpractice law, hospital management, legal medicine, and clinical risk management. The symposium's rationale was the highly likely inflation of criminal and civil proceedings concerning alleged errors committed by health care professionals and decision makers during the COVID-19 pandemic. Its aim was to identify and discuss the main issues of legal and medicolegal interest and thus to find solid solutions in the spirit of preparedness planning. METHODS: There were 5 main points of discussion: (A) how to judge errors committed during the pandemic because of the application of protocols and therapies based on no or weak evidence of efficacy, (B) whether hospital managers can be considered liable for infected health care professionals who were not given adequate personal protective equipment, (C) whether health care professionals and institutions can be considered liable for cases of infected inpatients who claim that the infection was transmitted in a hospital setting, (D) whether health care institutions and hospital managers can be considered liable for the hotspots in long-term care facilities/care homes, and (E) whether health care institutions and hospital managers can be considered liable for the worsening of chronic diseases. RESULTS AND CONCLUSION: Limitation of the liability to the cases of gross negligence (with an explicit definition of this term), a no-fault system with statal indemnities for infected cases, and a rigorous methodology for the expert witnesses were proposed as key interventions for successfully facing future proceedings.

Published
2020

5. Effectiveness of Switching to Darunavir/Cobicistat in Virologically Suppressed HIV-Positive Patients Receiving Ritonavir-Boosted Protease Inhibitor–Based Regimen: The 'STORE' Study

Author

Alessandra Vergori, Elio Manzillo, Roberta Termini, Andrea Antinori, Diego Ripamonti, Antonella dʼArminio Monforte, Christof Stingone, Nicola Gianotti, Stefano Savinelli, Benedetto Maurizio Celesia, Francesco Castelli, Renato Maserati, Teresa Santantonio, Giancarlo Orofino, Barbara Menzaghi, Francesco Rucci, Maria Vittoria Cossu, Roberto Cauda, Gaetana Sterrantino, Anna Maria Cattelan, Alessia Uglietti, Andrea Gori, Stefano Rusconi, Daniela Mancusi, and Stefano Bonora

Subjects
Adult, Male, medicine.medical_specialty, Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, Anti-HIV Agents, effectiveness, HIV Infections, 030312 virology, darunavir, cobicistat, ritonavir, HIV, STORE, virologically suppressed, Gastroenterology, 03 medical and health sciences, Internal medicine, HIV Seropositivity, medicine, Humans, darunavir/ritonavir, Pharmacology (medical), Prospective Studies, Adverse effect, Prospective cohort study, Darunavir, therapy, 0303 health sciences, Ritonavir, business.industry, Cobicistat, darunavir/cobicistat, HIV Protease Inhibitors, Middle Aged, Viral Load, Clinical Science, Regimen, Infectious Diseases, Tolerability, haart, HIV-1, RNA, Viral, Female, business, Viral load, medicine.drug
Abstract

Objective: This study investigates the effectiveness and tolerability of switching to a darunavir/cobicistat (DRV/c)-based antiretroviral regimen from a ritonavir-boosted protease inhibitor (PI/r)-based regimen in virologically suppressed HIV-positive patients. DRV trough values were also investigated. Setting: Prospective, multicenter, single-country, noninterventional cohort study. Methods: This study included patients on a PI/r-based ART for at least 12 months having plasma HIV-1 RNA

Published
2020

6. Has COVID-19 changed the approach to HIV diagnosis?

Author

Gianmaria Baldin, Giovanni Guaraldi, Carlo Torti, Bianca Candelaresi, Vanni Borghi, Gaetana Sterrantino, Cristina Mussini, Filippo Lagi, Simona Di Giambenedetto, Andrea Giacomelli, Roberto Cauda, Letizia Oreni, Arturo Ciccullo, Stefano Rusconi, Andrea De Vito, Oscar Cirioni, Barbara Rossetti, and Maria Mazzitelli

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Cross-sectional study, Observational Study, HIV Infections, Disease, Settore MED/17 - MALATTIE INFETTIVE, CD4 Lymphocyte Count, COVID-19, Cross-Sectional Studies, Delivery of Health Care, Female, Humans, Italy, Mass Screening, Middle Aged, Pandemics, Retrospective Studies, Risk Factors, SARS-CoV-2, Men who have sex with men, lockdown, Acquired immunodeficiency syndrome (AIDS), Health care, Pandemic, medicine, late presentation, Mass screening, business.industry, Incidence (epidemiology), virus diseases, HIV, General Medicine, medicine.disease, AIDS, business, Research Article
Abstract

The occurrence of COVID-19 pandemic had a significant negative effect on health care systems over the last year. Health care providers were forced to focus mainly on COVID-19 patients, neglecting in many cases equally important diseases, both acute and chronic. Therefore, also screening and diagnostic strategies for HIV could have been significantly impaired. This retrospective, multicenter, observational study aimed at assessing the number and characteristics of new HIV/AIDS diagnoses during COVID-19 pandemic in Italy and compared characteristics of people living with HIV at diagnosis between pre- and post-COVID-19 era (2019 vs 2020). Our results showed a significant reduction of HIV diagnoses during pandemic. By contrast, people living with HIV during pandemic were older and were diagnosed in earlier stage of disease (considering CD4+ T cell count) compared to those who were diagnosed the year before. Moreover, there was a significant decrease of new HIV diagnoses among men who have sex with men, probably for the impact of social distancing and restriction applied by the Italian Government. Late presentation incidence, if numbers in 2020 were lower than those in 2019, is still an issue. Routinely performing HIV testing in patients with suspected SARS-CoV-2 infection is identifying and linking to care underdiagnosed people living with HIV earlier. Thus, combined tests (HIV and SARS-CoV-2) should be implemented in patients with SARS-CoV-2 symptoms overlapping HIV's ones. Lastly, our results lastly showed how urgent implementation of a national policy for HIV screening is necessary.

Published
2021

7. Prevalence of Sexually Transmitted Infections and Factors Associated with HIV Status Among Vulnerable Women in Northern Uganda: Baseline Results from Pe Atye Kena Cohort Study

Author

Francesco Vladimiro Segala, F Aloi, E Ochola, Antonella Cingolani, R Lukwiya, K. de Gaetano Donati, Giulia Micheli, Roberto Cauda, B Odong, C Seguiti, and A Pierantozzi

Subjects
Sexual partner, education.field_of_study, business.industry, Population, virus diseases, Hematology, medicine.disease, law.invention, Sexual intercourse, Infectious Diseases, Condom, law, Female empowerment, Cohort, Sexually transmitted infections, Medicine, Syphilis, Original Article, Women, Uganda, business, education, Demography, Cohort study, Reproductive health
Abstract

Background and Objectives HIV infection among vulnerable women (VW) has been attributed to unfavourable power relations and limited access to sexual and reproductive health information and services. This work aims to report sexually-transmitted infections (STI) prevalence and assess the impact of HIV awareness, demographic and socio-behavioural factors on HIV status in a rural area of northern Uganda. Methods Pe Atye Kena is a longitudinal cohort intervention study enrolling young women aged 18–49 years old living in the municipality of Gulu, Uganda. HIV, HBV, syphilis serologic tests, and a comprehensive electronic questionnaire on sexual high-risk behaviours were administered before intervention. In this work, we report baseline characteristics of the population along with factors associated with HIV status. Statistical analysis was performed by uni- and multivariable regression models. Results 461 VW were enrolled (mean age: 29 (SD7.7)). 40 (8.7%) were found to be positive for HIV, 42 (9.1%) for syphilis and 29 (6.3%) for HBV. Older age (> 34 years vs. < 24 years; OR 4.95, 95% CI: 1.7 to 14); having done the last HIV test > 12m before the interview (OR 5.21, 95% CI: 2.3 to 11); suspecting the male sexual partner to be HIV+ (OR 2.2; 95% CI: 1.1 to 4.3); not having used condom at first sexual intercourse (OR 2.6; 95% CI 1.3 to 5.15) were all factors associated with an incident HIV diagnosis. Conclusions In this cohort, HIV prevalence is high, and sexual high-risk behaviours are multifaced; future interventions will be aimed to reduce HIV/STIs misconceptions and to promote a sense of community, self-determination and female empowerment.

Published
2021

8. Long-Term Serological Response to 13-Valent Pneumococcal Conjugate Vaccine Versus 23-Valent Polysaccharide Vaccine in HIV-Infected Adults

Author

Francesca Lombardi, L. Paglicci, Andrea De Luca, Roberto Cauda, Barbara Rossetti, Alberto Borghetti, Francesca Montagnani, Chiara Picarelli, Arturo Ciccullo, Simone Belmonti, and Sara Modica

Subjects
0301 basic medicine, Microbiology (medical), Serotype, Pneumococcal vaccination, 030106 microbiology, PCV13, Polysaccharide Vaccine, medicine.disease_cause, Settore MED/17 - MALATTIE INFETTIVE, Serologic response, Pneumococcal conjugate vaccine, Serology, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, 0302 clinical medicine, Antigen, PPV23, Streptococcus pneumoniae, medicine, lcsh:RC109-216, 030212 general & internal medicine, HIV, business.industry, Immunogenicity, Brief Report, Vaccination, Infectious Diseases, Immunology, business, medicine.drug
Abstract

Introduction Long-term comparative immunologic response to 13-valent pneumococcal conjugate vaccine (PCV13) versus 23-valent polysaccharide vaccine (PPV23) among HIV-infected adults has not yet been investigated. Methods In this prospective pilot study, we quantified in HIV-positive adults serotype-specific IgG concentrations of the 12 pneumococcal serotypes shared by both vaccines 5 years after vaccination with two doses of PCV13 8 weeks apart (group 1) or one dose of PPV23 (group 2) and compared them with those assessed prior to vaccination (BL) and after 1 year (T1). Comparison of immunogenicity was based on geometric mean concentration (GMC), proportion of individuals with ≥ twofold increase from BL in specific antibody concentration against ≥ 2 serotypes and percentage of individuals with serotype-specific IgG ≥ 0.35 μg/ml, ≥ 1 μg/ml and ≥ individual serotype-specific correlates of protection. Results We included 91 subjects (median CD4+ 650 cells/µl, > 90% with HIV-RNA

Published
2019

9. Role of place of acquisition and inappropriate empirical antibiotic therapy on the outcome of extended-spectrum β-lactamase-producing Enterobacteriaceae infections

Author

Angelo Pan, Nico T. Mutters, Alessandro Bartoloni, Lia A. Beccara, Gian Maria Rossolini, Elisabetta Mantengoli, Maria Adriana Cataldo, A. Raglio, Francesco Luzzaro, Evelina Tacconelli, Elena Carrara, Marco Tinelli, Patrizia Pecile, and Roberto Cauda

Subjects
Male, 0301 basic medicine, Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, 0302 clinical medicine, 80 and over, Risk of mortality, Pharmacology (medical), Prospective Studies, 030212 general & internal medicine, Prospective cohort study, Aged, 80 and over, High rate, Enterobacteriaceae Infections, Mortality rate, Extended spectrum beta-lactamase, General Medicine, Middle Aged, Community-acquired infection, Anti-Bacterial Agents, Treatment Outcome, Infectious Diseases, Female, Community acquired infection, Inappropriate antibiotic therapy, ESBL, Extended-spectrum β-lactamase, Adolescent, Adult, Aged, Drug Therapy, Enterobacteriaceae, Humans, Survival Analysis, Young Adult, beta-Lactamases, beta-Lactam Resistance, Microbiology (medical), medicine.medical_specialty, 030106 microbiology, Empirical antibiotic therapy, 03 medical and health sciences, Internal medicine, Surgical site, medicine, business.industry, medicine.disease, Pneumonia, business
Abstract

The impact of inappropriate empirical antibiotic therapy (IEAT) on the outcome of severe infections due to extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-Ent) remains unclear. Current evidence is limited by study design and lack of confounder control. The main objective of this study was to define the outcome of severe infections due to ESBL-Ent according to clinical parameters and place of infection acquisition. Adult hospitalised patients with ESBL-Ent infections were included in a 3-year multicentre prospective study. Primary outcomes were IEAT rates and crude mortality of severe infections, adjusted by place of acquisition [community-acquired infection (CAI), healthcare-associated infection (HCAI) and hospital-acquired infection (HAI)]. Among 729 patients, 519 (71.2%) were diagnosed with HAI, 176 (24.1%) with HCAI and 34 (4.7%) with CAI. Moreover, 32.9% of patients received IEAT; higher rates of IEAT were observed in pneumonia (23%) and deep surgical site infections (19%). HCAIs were more frequently associated with IEAT than HAIs (48.3% vs. 27.9%; OR = 1.7, 95% CI 1.2–2.4). The overall mortality rate for severe infections (n = 264) was 12.1% and was significantly higher in HCAIs (20%) than HAIs (10%) (RR = 2.3, 95% CI 1.01–5.3). IEAT significantly increased the risk of mortality in bloodstream infections (RR = 8.3, 95% CI 2–46.3). Rates of IEAT and overall mortality of ESBL-Ent severe infections were higher in HCAIs than HAIs. Prompt diagnosis of patients with severe HCAIs due to ESBL-Ent is essential since these infections receive high rates of IEAT and significantly higher mortality than HAIs [ClinicalTrials.gov Identifier: NCT00404625].

Published
2019

10. Lamivudine‐based maintenance antiretroviral therapies in patients living with <scp>HIV</scp> ‐1 with suppressed HIV <scp>RNA</scp> : derivation of a predictive score for virological failure

Author

Simone Belmonti, Gianmaria Baldin, Francesca Lombardi, S Di Giambenedetto, Roberto Cauda, A. Antinori, D Speziale, Antonella Cingolani, Arturo Ciccullo, Davide Moschese, Alberto Borghetti, and Arianna Emiliozzi

Subjects
Adult, Male, 0301 basic medicine, Oncology, medicine.medical_specialty, Anti-HIV Agents, protease inhibitors, HIV Infections, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Predictive Value of Tests, Internal medicine, Drug Resistance, Viral, medicine, Humans, Pharmacology (medical), Protease inhibitor (pharmacology), 030212 general & internal medicine, dolutegravir, highly active antiretroviral therapy, HIV, therapy switch, Retrospective Studies, business.industry, Proportional hazards model, Health Policy, Lamivudine, Middle Aged, Viral Load, Resistance mutation, 030112 virology, Confidence interval, CD4 Lymphocyte Count, Infectious Diseases, chemistry, Dolutegravir, Cohort, HIV-1, RNA, Viral, Female, business, Follow-Up Studies, medicine.drug, Cohort study
Abstract

OBJECTIVES Two-drug antiretroviral regimens based on lamivudine (3TC) plus either a protease inhibitor (PI) or dolutegravir (DTG) are becoming increasingly popular in switch strategies. Our goal was to derive a predictive score for virological failure (VF). METHODS We retrospectively analysed data for a cohort of 587 virologically suppressed (HIV RNA

Published
2019

11. Durability of different initial regimens in HIV-infected patients starting antiretroviral therapy with CD4+ counts <200 cells/mm3 and HIV-RNA >5 log10 copies/mL

Author

Bruno Cacopardo, M. A. Ursitti, Claudio Maria Mastroianni, Emanuele Nicastri, R. Piolini, A. Antinori, Giustino Parruti, S. Truffa, Ivan Gentile, Giovanni Cassola, E. Girardi, I. Caramma, Andrea Calcagno, Laura Monno, A d'Arminio Monforte, R. Acinapura, Francesca Ceccherini-Silberstein, A. Di Biagio, Gabriella Verucchi, Alessandra Latini, Simone Marcotullio, Nicola Gianotti, C. Balotta, Camilla Tincati, M. C. Moioli, Alessandro Tavelli, Pietro Caramello, Carmen Rita Santoro, C. Abeli, A. Londero, F. Di Martino, R. Iardino, Stefano Bonora, M. Andreoni, A. Costantini, Raffaella Libertone, F. von Schloesser, G. Prota, Annalisa Saracino, Maria Grazia Cecchetto, Antonio Cristaudo, Mauro Zaccarelli, Carmela Pinnetti, Fabrizio Carletti, N. Abrescia, Andrea Giacometti, L. Gallo, Paolo Bonfanti, G. Angarano, E. Quiros Roldan, G. Pellizzer, F. Petrone, Giovanni Mazzarello, Silvia Nozza, R. Orlando, Franco Baldelli, Giovanni Guaraldi, Paola Meraviglia, Laura Sighinolfi, S. Carrara, D. Segala, Giuliano Rizzardini, C. Suardi, P. Piano, Mauro Sciandra, Daniela Francisci, A. De Luca, Patrizia Lorenzini, Paola Cinque, Tiziana Quirino, S. Graziano, Cristina Mussini, Massimo Galli, Giuseppe Ippolito, S. Lo Caputo, Benedetto Maurizio Celesia, C. Valeriani, Matteo Bassetti, Maria Rosaria Capobianchi, Claudio Viscoli, Vinicio Manfrin, Alessandro Chiodera, Alessandra Bandera, Guglielmo Borgia, Cinzia Puzzolante, Stefano Rusconi, Leonardo Calza, Valeria Belvisi, Francesca Vichi, Serena Quartu, Roberto Cauda, J. Vecchiet, Antonio Chirianni, A. Di Caro, P.E. Manconi, Stefania Cicalini, G. Magnani, M. Lichtner, Milensu Shanyinde, Stefano Savinelli, M. Puoti, Giulia Marchetti, Laura Carenzi, Carlo Federico Perno, Annalisa Ridolfo, G. Di Perri, F. Maggiolo, A Castagna, G. Orofino, Roberto Rossotti, Francesco Mazzotta, Gianmaria Baldin, Giovanni Lapadula, A. Rodano, V. Donati, Barbara Rossetti, F. Viviani, Adriana Ammassari, N. Bobbio, Adriano Lazzarin, C. Minardi, A. Alessandrini, Katia Falasca, Maria Stella Mura, Tamara Ursini, Andrea Gori, A. Cingolani, L. Maddaloni, Alessandro Cozzi-Lepri, Francesco Castelli, Iuri Fanti, Giordano Madeddu, E. Quiros, P. Viale, Marco Borderi, M. Capozzi, and Vincenzo Vullo

Subjects
Adult, Male, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Anti-HIV Agents, Hepatitis C virus, Renal function, Integrase inhibitor, HIV Infections, medicine.disease_cause, Rate ratio, 03 medical and health sciences, 0302 clinical medicine, Antiretroviral Therapy, Highly Active, Internal medicine, Clinical endpoint, Humans, Medicine, Pharmacology (medical), Treatment Failure, 030212 general & internal medicine, Retrospective Studies, Pharmacology, AIDS-Related Opportunistic Infections, Coinfection, business.industry, Retrospective cohort study, Middle Aged, Viral Load, 030112 virology, CD4 Lymphocyte Count, Discontinuation, Treatment Outcome, Infectious Diseases, Cohort, Female, business
Abstract

ObjectivesOur aim was to investigate the durability of different initial regimens in patients starting ART with CD4+ counts 5 log10 copies/mL.MethodsThis was a retrospective study of HIV-infected patients prospectively followed in the ICONA cohort. Those who started ART with boosted protease inhibitors (bPIs), NNRTIs or integrase strand transfer inhibitors (InSTIs), with CD4+ 5 log10 copies/mL, were included. The primary endpoint was treatment failure (TF), a composite endpoint defined as virological failure (VF, first of two consecutive HIV-RNA >50 copies/mL after 6 months of treatment), discontinuation of class of the anchor drug or death. Independent associations were investigated by Poisson regression analysis in a model including age, gender, mode of HIV transmission, CDC stage, HCV and HBV co-infection, pre-treatment HIV-RNA, CD4+ count and CD4+/CD8+ ratio, ongoing opportunistic disease, fibrosis FIB-4 index, estimated glomerular filtration rate, haemoglobin, platelets, neutrophils, calendar year of ART initiation, anchor drug class (treatment group) and nucleos(t)ide backbone.ResultsA total of 1195 patients fulfilled the inclusion criteria: 696 started ART with a bPI, 315 with an InSTI and 184 with an NNRTI. During 2759 person-years of follow up, 642 patients experienced TF. Starting ART with bPIs [adjusted incidence rate ratio (aIRR) (95% CI) 1.62 (1.29–2.03) versus starting with NNRTIs; P ConclusionsIn patients starting ART with 5 log10 HIV-RNA copies/mL, the durability of regimens based on InSTIs was longer than that of NNRTI- and bPI-based regimens.

Published
2019

12. Psychological distress during the initial COVID-19 pandemic in an Italian cohort of people living with HIV: an online survey

Author

Nicoletta Ciccarelli, Francesca Lombardi, Simona Di Giambenedetto, Roberto Cauda, Alberto Borghetti, Valentina Massaroni, Massimiliano Fabbiani, Silvia Lamonica, and Valentina Delle Donne

Subjects
Gerontology, Coronavirus disease 2019 (COVID-19), business.industry, Cohort, Pandemic, Human immunodeficiency virus (HIV), medicine, Psychological distress, medicine.disease_cause, business
Abstract

Our aim was to explore the psychological impact of the initial 2019 Coronavirus (COVID-19) pandemic in a cohort of people living with HIV (PLWH), a population at increased risk of psychological distress. PLWH, treated at our unit, responded an online survey. Data on demographics, clinical and physical symptoms, contact history, as well as knowledge, concerns, precautionary measures and additional information required with respect to COVID-19 during the first phase of the pandemic in Italy were collected. Additionally, the Impact of Event Scale-Revised (IES-R) (identifying COVID-19 pandemic as specific traumatic life event) and the Depression, Anxiety and Stress Scale (DASS-21) were also administered. Out of 98 participants, 44 (45%) revealed from mild to severe psychological impact distress from COVID-19 according to IES-R. According to DASS-21, a lower percentage of significant levels of depression (14%), anxiety (11%) or stress (6%) were reported. Higher education, unemployment, number of perceived physical COVID-19 symptoms, concerns contracting COVID-19 and the situation regarding the pandemic in Italy, and the need of additional information to prevent COVID-19 infection were positively associated to psychological distress. Moreover, female gender, older age, recent HIV diagnosis and unawareness of own viremia were associated to a higher psychological distress. Almost half of our cohort experienced significant levels of distress related to the COVID-19 pandemic. Women, elderly patients and those with recent HIV diagnosis resulted to be the more psychological fragile subgroup. Our findings could help to identify patients in need of psychological interventions to improve wellbeing of PLWH.

Published
2021

13. Heparin in COVID-19 patients is associated with reduced in-hospital mortality: the multicentre Italian CORIST Study

Author

Walter Ageno, Raffaele Pesavento, Marinella Astuto, Katleen de Gaetano Donati, Francesca Santilli, Filippo Aucella, Eleonora Taddei, Marianna Meschiari, Laura Scorzolini, Biagio Pinchera, Giustino Parruti, Licia Iacoviello, Andrea Vianello, Gabriella Guarnieri, Arturo Montineri, Crizia Colombo, Carlo Signorelli, Lorenzo Blandi, Raffaele De Caterina, Maria Musso, Francesco Petri, Stefano Maitan, Anna Odone, Lucia Caiano, Francesca Crosta, Lorenzo Marra, Giuseppe Patti, Emanuela Pasi, Jovana Milic, Marco Olivieri, Claudia Colomba, Francesco Maria Fusco, Claudia Ravaglia, Alexandra Virano, Carlo Torti, Samir Al Moghazi, Venerino Poletti, Riccardo Maragna, Carlo Sanrocco, Sandro Mancarella, Greta Barbieri, Arturo Ciccullo, Leonardo Grisafi, Paola Simeone, Lorenzo Menicanti, Antonella Palimodde, Gloria Maccagni, Alessandra Vergori, Daniela Niola, Marco G. Mennuni, Gianpiero D'Offizi, Claudia Marotta, Damiano D'Ardes, Vincenzo Sangiovanni, Paolo Bonfanti, Giovanni Larizza, Francesco Di Gennaro, Alessandro Mengozzi, Massimo Mapelli, Giuseppe Di Tano, Laura Carrozzi, Antonella Agodi, Francesco Menichetti, Marialaura Bonaccio, Andrea Antinori, Marco Vinceti, Armando Leone, Franco Mastroianni, Silvia Marongiu, Filippo Minutolo, Giulio Maresca, Beatrice Molena, Nausicaa Berselli, Francesco Cipollone, Massimo Fantoni, Antonella Cingolani, Giovanni Guaraldi, Raffaella Sgariglia, Piergiuseppe Agostoni, Antonio Cascio, Maria Mazzitelli, Roberta Parisi, Augusto Di Castelnuovo, Gian Battista Danzi, Luca Aiello, Roberto Vettor, Elvira Grandone, Laura Vocciante, Emauele Graziani, Cristina Mussini, Marianna Rossi, Marco Rossato, Roberto Cauda, Rosa Arboretti, Alessandro Bartoloni, Simona Costanzo, Francesco Gianfagna, Andrea Rognoni, Ferruccio Madaro, Rossella Marcucci, Pasquale Abete, Francesco Cacciatore, Ivan Gentile, Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Cauda, R, Guaraldi, G, Menicanti, L, Mennuni, M, Parruti, G, Patti, G, Santilli, F, Signorelli, C, Vergori, A, Abete, P, Ageno, W, Agodi, A, Agostoni, P, Aiello, L, Al Moghazi, S, Arboretti, R, Astuto, M, Aucella, F, Barbieri, G, Bartoloni, A, Bonfanti, P, Cacciatore, F, Caiano, L, Carrozzi, L, Cascio, A, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Fantoni, M, Fusco, F, Gentile, I, Gianfagna, F, Grandone, E, Graziani, E, Grisafi, L, Guarnieri, G, Larizza, G, Leone, A, Maccagni, G, Madaro, F, Maitan, S, Mancarella, S, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marongiu, S, Marotta, C, Marra, L, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Milic, J, Minutolo, F, Molena, B, Montineri, A, Mussini, C, Musso, M, Niola, D, Odone, A, Olivieri, M, Palimodde, A, Parisi, R, Pasi, E, Pesavento, R, Petri, F, Pinchera, B, Poletti, V, Ravaglia, C, Rognoni, A, Rossato, M, Rossi, M, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Taddei, E, Torti, C, Vettor, R, Vianello, A, Vinceti, M, Virano, A, Vocciante, L, De Caterina, R, Iacoviello, L, Danzi, G. B, De Gaetano Donati, K, Fusco, F. M, Simeone, P. G, Iacoviello, L., Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Cauda, Roberto, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, Parruti, Giustino, Patti, Giuseppe, Santilli, Francesca, Signorelli, Carlo, Vergori, Alessandra, Abete, Pasquale, Ageno, Walter, Agodi, Antonella, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Arboretti, Rosa, Astuto, Marinella, Aucella, Filippo, Barbieri, Greta, Bartoloni, Alessandro, Bonfanti, Paolo, Cacciatore, Francesco, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Crosta, Francesca, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Fantoni, Massimo, Fusco, Francesco Maria, Gentile, Ivan, Gianfagna, Francesco, Grandone, Elvira, Graziani, Emauele, Grisafi, Leonardo, Guarnieri, Gabriella, Larizza, Giovanni, Leone, Armando, Maccagni, Gloria, Madaro, Ferruccio, Maitan, Stefano, Mancarella, Sandro, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marongiu, Silvia, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Meschiari, Marianna, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Montineri, Arturo, Mussini, Cristina, Musso, Maria, Niola, Daniela, Odone, Anna, Olivieri, Marco, Palimodde, Antonella, Parisi, Roberta, Pasi, Emanuela, Pesavento, Raffaele, Petri, Francesco, Pinchera, Biagio, Poletti, Venerino, Ravaglia, Claudia, Rognoni, Andrea, Rossato, Marco, Rossi, Marianna, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Taddei, Eleonora, Torti, Carlo, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Virano, Alexandra, Vocciante, Laura, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo A., Costanzo S., Antinori A., Berselli N., Blandi L., Bonaccio M., Cauda R., Guaraldi G., Menicanti L., Mennuni M., Parruti G., Patti G., Santilli F., Signorelli C., Vergori A., Abete P., Ageno W., Agodi A., Agostoni P., Aiello L., Al Moghazi S., Arboretti R., Astuto M., Aucella F., Barbieri G., Bartoloni A., Bonfanti P., Cacciatore F., Caiano L., Carrozzi L., Cascio A., Ciccullo A., Cingolani A., Cipollone F., Colomba C., Colombo C., Crosta F., Danzi G.B., D'Ardes D., De Gaetano Donati K., Di Gennaro F., Di Tano G., D'Offizi G., Fantoni M., Fusco F.M., Gentile I., Gianfagna F., Grandone E., Graziani E., Grisafi L., Guarnieri G., Larizza G., Leone A., MacCagni G., Madaro F., Maitan S., Mancarella S., Mapelli M., Maragna R., Marcucci R., Maresca G., Marongiu S., Marotta C., Marra L., Mastroianni F., Mazzitelli M., Mengozzi A., Menichetti F., Meschiari M., Milic J., Minutolo F., Molena B., Montineri A., Mussini C., Musso M., Niola D., Odone A., Olivieri M., Palimodde A., Parisi R., Pasi E., Pesavento R., Petri F., Pinchera B., Poletti V., Ravaglia C., Rognoni A., Rossato M., Rossi M., Sangiovanni V., Sanrocco C., Scorzolini L., Sgariglia R., Simeone P.G., Taddei E., Torti C., Vettor R., Vianello A., Vinceti M., Virano A., Vocciante L., De Caterina R., and Iacoviello L.

Subjects
Male, medicine.medical_specialty, Settore MED/17 - Malattie Infettive, coronavirus, heparin, 030204 cardiovascular system & hematology, Lower risk, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Clinical endpoint, medicine, Humans, Thrombophilia, 030212 general & internal medicine, Hospital Mortality, Blood Coagulation, Survival analysis, Aged, Retrospective Studies, treatment, business.industry, Heparin, Mortality rate, COVID-19,mortality, Low-Molecular-Weight, Anticoagulants, COVID-19, Retrospective cohort study, Hematology, Heparin, Low-Molecular-Weight, Middle Aged, mortality, Survival Analysis, COVID-19 Drug Treatment, coagulation activation, coronaviru, Italy, treatments, Propensity score matching, Female, business, medicine.drug
Abstract

Introduction A hypercoagulable condition was described in patients with coronavirus disease 2019 (COVID-19) and proposed as a possible pathogenic mechanism contributing to disease progression and lethality. Aim We evaluated if in-hospital administration of heparin improved survival in a large cohort of Italian COVID-19 patients. Methods In a retrospective observational study, 2,574 unselected patients hospitalized in 30 clinical centers in Italy from February 19, 2020 to June 5, 2020 with laboratory-confirmed severe acute respiratory syndrome coronavirus-2 infection were analyzed. The primary endpoint in a time-to event analysis was in-hospital death, comparing patients who received heparin (low-molecular-weight heparin [LMWH] or unfractionated heparin [UFH]) with patients who did not. We used multivariable Cox proportional-hazards regression models with inverse probability for treatment weighting by propensity scores. Results Out of 2,574 COVID-19 patients, 70.1% received heparin. LMWH was largely the most used formulation (99.5%). Death rates for patients receiving heparin or not were 7.4 and 14.0 per 1,000 person-days, respectively. After adjustment for propensity scores, we found a 40% lower risk of death in patients receiving heparin (hazard ratio = 0.60; 95% confidence interval: 0.49–0.74; E-value = 2.04). This association was particularly evident in patients with a higher severity of disease or strong coagulation activation. Conclusion In-hospital heparin treatment was associated with a lower mortality, particularly in severely ill COVID-19 patients and in those with strong coagulation activation. The results from randomized clinical trials are eagerly awaited to provide clear-cut recommendations.

Published
2021

14. Derivation and validation of a scoring system to assess pre-test probability of being COVID-19 positive

Author

Antonio Gasbarrini, Alberto Borghetti, Arturo Ciccullo, Paola Cattani, L. Zileri Dal Verme, Roberto Cauda, Antonio Marchetti, F Rovedi, S Di Giambenedetto, L Stella, and M Paratore

Subjects
Microbiology (medical), 2019-20 coronavirus outbreak, China, Scoring system, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Pneumonia, Viral, Settore MED/17 - MALATTIE INFETTIVE, Article, Betacoronavirus, Lymphopenia, Diagnosis, Medicine, Humans, Derivation, Pandemics, Probability, business.industry, SARS-CoV-2, Score, COVID-19, Pneumonia, medicine.disease, Virology, Pre- and post-test probability, Coronavirus, Infectious Diseases, business, Coronavirus Infections
Published
2021
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15. Disentangling the Association of Hydroxychloroquine Treatment with Mortality in Covid-19 Hospitalized Patients through Hierarchical Clustering

Author

Anna Sabena, Gabriele Giuliano, Raffaele Bruno, Francesco Cacciatore, Carlo Torti, Silvia Marongiu, Gloria Maccagni, Claudia Marotta, Giovanni Larizza, Francesco Petri, Massimo Mapelli, Giulio Maresca, Giulia Righetti, Alessandra Vergori, Ilaria Rossi, Damiano D'Ardes, Nicola Schiano Moriello, Ivan Gentile, Enrica Tamburrini, Luca Aiello, Piergiuseppe Agostoni, Antonio Cascio, Jovana Milic, Carlo Andrea Pivato, Agostino Virdis, Stefano Maitan, Francesco Cannata, Simona Costanzo, Carlo Signorelli, Franco Mastroianni, Federica Magni, Crizia Colombo, Giulio G. Stefanini, Lucia Caiano, Francesca Crosta, Lorenzo Marra, Giuseppe Patti, Katleen de Gaetano Donati, Valerio Langella, Annalisa Crisetti, Filippo Aucella, Antonella Cingolani, Francesco Salinaro, Augusto Di Castelnuovo, Giacomo Castiglione, Alessandro Gialluisi, Anna Odone, Cristina Mussini, Samir Al Moghazi, Lorenzo Blandi, Maria Musso, Marialaura Bonaccio, Raffaele De Caterina, Marco Olivieri, Roberto Cauda, Emanuela Pasi, Arturo Ciccullo, Stefano Perlini, Claudia Colomba, Antonella Palimodde, Gianpiero D'Offizi, Marco G. Mennuni, Walter Ageno, Raffaele Pesavento, Rosa Manuele, Roberta Mussinelli, Vincenzo Sangiovanni, Paolo Bonfanti, Andrea Antinori, Francesco Gianfagna, Andrea Rognoni, Laura Scorzolini, Riccardo Maragna, Rossella Marcucci, Filippo Minutolo, Armando Leone, Giustino Parruti, Licia Iacoviello, Lorenzo Menicanti, Sandro Mancarella, Rosa Arboretti, Greta Barbieri, Carlo Gaudiosi, Marco Rossato, Claudia Ravaglia, Andrea Vianello, Marianna Rossi, Emauele Graziani, Martina Barchitta, Giovanni Guaraldi, Enrico Maria Trecarichi, Gian Battista Danzi, Francesco Cipollone, Carlo Sanrocco, Marco Vinceti, Francesca Santilli, Marianna Meschiari, Gabriella Guarnieri, Antonella Agodi, Roberto Vettor, Raffaella Sgariglia, Ilaria My, Francesco Di Gennaro, Alessandro Mengozzi, Giuseppe Di Tano, Laura Carrozzi, Michele Spinicci, Venerino Poletti, Paola Simeone, Nausicaa Berselli, Francesco Maria Fusco, Di Castelnuovo A., Gialluisi A., Antinori A., Berselli N., Blandi L., Bonaccio M., Bruno R., Cauda R., Costanzo S., Guaraldi G., Menicanti L., Mennuni M., My I., Parruti G., Patti G., Perlini S., Santilli F., Signorelli C., Stefanini G., Vergori A., Ageno W., Agodi A., Agostoni P., Aiello L., Moghazi S.A., Arboretti R., Aucella F., Barbieri G., Barchitta M., Bonfanti P., Cacciatore F., Caiano L., Cannata F., Carrozzi L., Cascio A., Castiglione G., Cicullo A., Cingolani A., Cipollone F., Colomba C., Colombo C., Crisetti A., Crosta F., Danzi G.B., D'Ardes D., de Gaetano Donati K., Di Gennaro F., Di Tano G., D'Offizi G., Fusco F.M., Gaudiosi C., Gentile I., Gianfagna F., Giuliano G., Graziani E., Guarnieri G., Langella V., Larizza G., Leone A., Maccagni G., Magni F., Maitan S., Mancarella S., Manuele R., Mapelli M., Maragna R., Marcucci R., Maresca G., Marongiu S., Marotta C., Marra L., Mastroianni F., Mengozzi A., Meschiari M., Milic J., Minutolo F., Mussinelli R., Mussini C., Musso M., Odone A., Olivieri M., Palimodde A., Pasi E., Pesavento R., Petri F., Pivato C.A., Poletti V., Ravaglia C., Righetti G., Rognoni A., Rossato M., Rossi I., Rossi M., Sabena A., Salinaro F., Sangiovanni V., Sanrocco C., Moriello N.S., Scorzolini L., Sgariglia R., Simeone P.G., Spinicci M., Tamburrini E., Torti C., Trecarichi E.M., Vettor R., Vianello A., Vinceti M., Virdis A., de Caterina R., Iacoviello L., Di Castelnuovo, A, Gialluisi, A, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Bruno, R, Cauda, R, Costanzo, S, Guaraldi, G, Menicanti, L, Mennuni, M, My, I, Parruti, G, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Ageno, W, Agodi, A, Agostoni, P, Aiello, L, Al Moghazi, S, Arboretti, R, Aucella, F, Barbieri, G, Barchitta, M, Bonfanti, P, Cacciatore, F, Caiano, L, Cannata, F, Carrozzi, L, Cascio, A, Castiglione, G, Cicullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Crisetti, A, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Fusco, F, Gaudiosi, C, Gentile, I, Gianfagna1, F, Giuliano, G, Graziani, E, Guarnieri, G, Langella, V, Larizza, G, Leone, A, Maccagni, G, Magni, F, Maitan, S, Mancarella, S, Manuele, R, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marongiu, S, Marotta, C, Marra, L, Mastroianni, F, Mengozzi, A, Meschiari, M, Milic, J, Minutolo, F, Mussinelli, R, Mussini, C, Musso, M, Odone, A, Olivieri, M, Palimodde, A, Pasi, E, Pesavento, R, Petri, F, Pivato, C, Poletti, V, Ravaglia, C, Righetti, G, Rognoni, A, Rossato, M, Rossi, I, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Schiano Moriello, N, Scorzolini, L, Sgariglia, R, Simeone, P, Spinicci, M, Tamburrini, E, Torti, C, Trecarichi, E, Vettor, R, Vianello, A, Vinceti, M, Virdis, A, De Caterina, R, Iacoviello, L, Di Castelnuovo, A., Gialluisi, A., Antinori, A., Berselli, N., Blandi, L., Bonaccio, M., Bruno, R., Cauda, R., Costanzo, S., Guaraldi, G., Menicanti, L., Mennuni, M., My, I., Parruti, G., Patti, G., Perlini, S., Santilli, F., Signorelli, C., Stefanini, G., Vergori, A., Ageno, W., Agodi, A., Agostoni, P., Aiello, L., Moghazi, S. A., Arboretti, R., Aucella, F., Barbieri, G., Barchitta, M., Bonfanti, P., Cacciatore, F., Caiano, L., Cannata, F., Carrozzi, L., Cascio, A., Castiglione, G., Cicullo, A., Cingolani, A., Cipollone, F., Colomba, C., Colombo, C., Crisetti, A., Crosta, F., Danzi, G. B., D’Ardes, D., de Gaetano Donati, K., Di Gennaro, F., Di Tano, G., D’Offizi, G., Fusco, F. M., Gaudiosi, C., Gentile, I., Gianfagna, F., Giuliano, G., Graziani, E., Guarnieri, G., Langella, V., Larizza, G., Leone, A., Maccagni, G., Magni, F., Maitan, S., Mancarella, S., Manuele, R., Mapelli, M., Maragna, R., Marcucci, R., Maresca, G., Marongiu, S., Marotta, C., Marra, L., Mastroianni, F., Mengozzi, A., Meschiari, M., Milic, J., Minutolo, F., Mussinelli, R., Mussini, C., Musso, M., Odone, A., Olivieri, M., Palimodde, A., Pasi, E., Pesavento, R., Petri, F., Pivato, C. A., Poletti, V., Ravaglia, C., Righetti, G., Rognoni, A., Rossato, M., Rossi, I., Rossi, M., Sabena, A., Salinaro, F., Sangiovanni, V., Sanrocco, C., Moriello, N. S., Scorzolini, L., Sgariglia, R., Simeone, P. G., Spinicci, M., Tamburrini, E., Torti, C., Trecarichi, E. M., Vettor, R., Vianello, A., Vinceti, M., Virdis, A., de Caterina, R., and Iacoviello, L.

Subjects
Male, Medicine (General), Antimalarial, 030204 cardiovascular system & hematology, Severity of Illness Index, Hospital Mortality, 0302 clinical medicine, Retrospective Studie, 80 and over, Cluster Analysis, 030212 general & internal medicine, Aged, Aged, 80 and over, Antimalarials, COVID-19, Female, Humans, Hydroxychloroquine, Italy, Middle Aged, Retrospective Studies, SARS-CoV-2, Treatment Outcome, Biotechnology, medicine.drug, Research Article, medicine.medical_specialty, Article Subject, Biomedical Engineering, Renal function, Health Informatics, 03 medical and health sciences, R5-920, Internal medicine, Diabetes mellitus, Severity of illness, medicine, Medical technology, R855-855.5, Cluster Analysi, business.industry, Cancer, Retrospective cohort study, medicine.disease, Obesity, COVID-19 Drug Treatment, Surgery, Observational study, business
Abstract

The efficacy of hydroxychloroquine (HCQ) in treating SARS-CoV-2 infection is harshly debated, with observational and experimental studies reporting contrasting results. To clarify the role of HCQ in Covid-19 patients, we carried out a retrospective observational study of 4,396 unselected patients hospitalized for Covid-19 in Italy (February–May 2020). Patients’ characteristics were collected at entry, including age, sex, obesity, smoking status, blood parameters, history of diabetes, cancer, cardiovascular and chronic pulmonary diseases, and medications in use. These were used to identify subtypes of patients with similar characteristics through hierarchical clustering based on Gower distance. Using multivariable Cox regressions, these clusters were then tested for association with mortality and modification of effect by treatment with HCQ. We identified two clusters, one of 3,913 younger patients with lower circulating inflammation levels and better renal function, and one of 483 generally older and more comorbid subjects, more prevalently men and smokers. The latter group was at increased death risk adjusted by HCQ (HR[CI95%] = 3.80[3.08-4.67]), while HCQ showed an independent inverse association (0.51[0.43-0.61]), as well as a significant influence of cluster∗HCQ interaction ( p < 0.001 ). This was driven by a differential association of HCQ with mortality between the high (0.89[0.65-1.22]) and the low risk cluster (0.46[0.39-0.54]). These effects survived adjustments for additional medications in use and were concordant with associations with disease severity and outcome. These findings suggest a particularly beneficial effect of HCQ within low risk Covid-19 patients and may contribute to clarifying the current controversy on HCQ efficacy in Covid-19 treatment.

Published
2021
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16. Lopinavir/ritonavir and darunavir/cobicistat in hospitalized covid-19 patients: Findings from the multicenter italian corist study

Author

Augusto Di Castelnuovo, Simona Costanzo, Andrea Antinori, Nausicaa Berselli, Lorenzo Blandi, Marialaura Bonaccio, Raffaele Bruno, Roberto Cauda, Alessandro Gialluisi, Giovanni Guaraldi, Lorenzo Menicanti, Marco Mennuni, Ilaria My, Agostino Parruti, Giuseppe Patti, Stefano Perlini, Francesca Santilli, Carlo Signorelli, Giulio G. Stefanini, Alessandra Vergori, Walter Ageno, Luca Aiello, Piergiuseppe Agostoni, Samir Al Moghazi, Rosa Arboretti, Filippo Aucella, Greta Barbieri, Martina Barchitta, Alessandro Bartoloni, Carolina Bologna, Paolo Bonfanti, Lucia Caiano, Laura Carrozzi, Antonio Cascio, Giacomo Castiglione, Mauro Chiarito, Arturo Ciccullo, Antonella Cingolani, Francesco Cipollone, Claudia Colomba, Crizia Colombo, Francesco Crosta, Giovanni Dalena, Chiara Dal Pra, Gian Battista Danzi, Damiano D'Ardes, Katleen de Gaetano Donati, Francesco Di Gennaro, Giuseppe Di Tano, Gianpiero D'Offizi, Tommaso Filippini, Francesco Maria Fusco, Carlo Gaudiosi, Ivan Gentile, Giancarlo Gini, Elvira Grandone, Gabriella Guarnieri, Gennaro L. F. Lamanna, Giovanni Larizza, Armando Leone, Veronica Lio, Angela Raffaella Losito, Gloria Maccagni, Stefano Maitan, Sandro Mancarella, Rosa Manuele, Massimo Mapelli, Riccardo Maragna, Lorenzo Marra, Giulio Maresca, Claudia Marotta, Franco Mastroianni, Maria Mazzitelli, Alessandro Mengozzi, Francesco Menichetti, Jovana Milic, Filippo Minutolo, Beatrice Molena, R. Mussinelli, Cristina Mussini, Maria Musso, Anna Odone, Marco Olivieri, Emanuela Pasi, Annalisa Perroni, Francesco Petri, Biagio Pinchera, Carlo A. Pivato, Venerino Poletti, Claudia Ravaglia, Marco Rossato, Marianna Rossi, Anna Sabena, Francesco Salinaro, Vincenzo Sangiovanni, Carlo Sanrocco, Laura Scorzolini, Raffaella Sgariglia, Paola Giustina Simeone, Michele Spinicci, Enrico Maria Trecarichi, Giovanni Veronesi, Roberto Vettor, Andrea Vianello, Marco Vinceti, Elena Visconti, Laura Vocciante, Raffaele De Caterina, Licia Iacoviello, The COVID-19 RISK and Treatments (CORIST) Collaboration, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Bruno, Raffaele, Cauda, Roberto, Gialluisi, Alessandro, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, My, Ilaria, Parruti, Agostino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G, Vergori, Alessandra, Ageno, Walter, Aiello, Luca, Agostoni, Piergiuseppe, Al Moghazi, Samir, Arboretti, Rosa, Aucella, Filippo, Barbieri, Greta, Barchitta, Martina, Bartoloni, Alessandro, Bologna, Carolina, Bonfanti, Paolo, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Castiglione, Giacomo, Chiarito, Mauro, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Crosta, Francesco, Dalena, Giovanni, Dal Pra, Chiara, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Filippini, Tommaso, Maria Fusco, Francesco, Gaudiosi, Carlo, Gentile, Ivan, Gini, Giancarlo, Grandone, Elvira, Guarnieri, Gabriella, Lamanna, Gennaro L F, Larizza, Giovanni, Leone, Armando, Lio, Veronica, Losito, Angela Raffaella, Maccagni, Gloria, Maitan, Stefano, Mancarella, Sandro, Manuele, Rosa, Mapelli, Massimo, Maragna, Riccardo, Marra, Lorenzo, Maresca, Giulio, Marotta, Claudia, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Mussinelli, R, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Pasi, Emanuela, Perroni, Annalisa, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A, Poletti, Venerino, Ravaglia, Claudia, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Spinicci, Michele, Trecarichi, Enrico Maria, Veronesi, Giovanni, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Visconti, Elena, Vocciante, Laura, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Bruno, R, Cauda, R, Gialluisi, A, Guaraldi, G, Menicanti, L, Mennuni, M, My, I, Parruti, A, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Ageno, W, Aiello, L, Agostoni, P, Al Moghazi, S, Arboretti, R, Aucella, F, Barbieri, G, Barchitta, M, Bartoloni, A, Bologna, C, Bonfanti, P, Caiano, L, Carrozzi, L, Cascio, A, Castiglione, G, Chiarito, M, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Crosta, F, Dalena, G, Dal Pra, C, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Filippini, T, Maria Fusco, F, Gaudiosi, C, Gentile, I, Gini, G, Grandone, E, Guarnieri, G, Lamanna, G, Larizza, G, Leone, A, Lio, V, Losito, A, Maccagni, G, Maitan, S, Mancarella, S, Manuele, R, Mapelli, M, Maragna, R, Marra, L, Maresca, G, Marotta, C, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Milic, J, Minutolo, F, Molena, B, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Perroni, A, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Spinicci, M, Trecarichi, E, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, Visconti, E, Vocciante, L, De Caterina, R, Iacoviello, L, Di Castelnuovo, A., Costanzo, S., Antinori, A., Berselli, N., Blandi, L., Bonaccio, M., Bruno, R., Cauda, R., Gialluisi, A., Guaraldi, G., Menicanti, L., Mennuni, M., My, I., Parruti, A., Patti, G., Perlini, S., Santilli, F., Signorelli, C., Stefanini, G. G., Vergori, A., Ageno, W., Aiello, L., Agostoni, P., Moghazi, S. A., Arboretti, R., Aucella, F., Barbieri, G., Barchitta, M., Bartoloni, A., Bologna, C., Bonfanti, P., Caiano, L., Carrozzi, L., Cascio, A., Castiglione, G., Chiarito, M., Ciccullo, A., Cingolani, A., Cipollone, F., Colomba, C., Colombo, C., Crosta, F., Dalena, G., Dal Pra, C., Danzi, G. B., D'Ardes, D., Donati, K. G., Di Gennaro, F., Di Tano, G., D'Offizi, G., Filippini, T., Fusco, F. M., Gaudiosi, C., Gentile, I., Gini, G., Grandone, E., Guarnieri, G., Lamanna, G. L. F., Larizza, G., Leone, A., Lio, V., Losito, A. R., Maccagni, G., Maitan, S., Mancarella, S., Manuele, R., Mapelli, M., Maragna, R., Marra, L., Maresca, G., Marotta, C., Mastroianni, F., Mazzitelli, M., Mengozzi, A., Menichetti, F., Milic, J., Minutolo, F., Molena, B., Mussinelli, R., Mussini, C., Musso, M., Odone, A., Olivieri, M., Pasi, E., Perroni, A., Petri, F., Pinchera, B., Pivato, C. A., Poletti, V., Ravaglia, C., Rossato, M., Rossi, M., Sabena, A., Salinaro, F., Sangiovanni, V., Sanrocco, C., Scorzolini, L., Sgariglia, R., Simeone, P. G., Spinicci, M., Trecarichi, E. M., Veronesi, G., Vettor, R., Vianello, A., Vinceti, M., Visconti, E., Vocciante, L., Caterina, R. D., Iacoviello, L., Di Castelnuovo A., Costanzo S., Antinori A., Berselli N., Blandi L., Bonaccio M., Bruno R., Cauda R., Gialluisi A., Guaraldi G., Menicanti L., Mennuni M., My I., Parruti A., Patti G., Perlini S., Santilli F., Signorelli C., Stefanini G.G., Vergori A., Ageno W., Aiello L., Agostoni P., Moghazi S.A., Arboretti R., Aucella F., Barbieri G., Barchitta M., Bartoloni A., Bologna C., Bonfanti P., Caiano L., Carrozzi L., Cascio A., Castiglione G., Chiarito M., Ciccullo A., Cingolani A., Cipollone F., Colomba C., Colombo C., Crosta F., Dalena G., Dal Pra C., Danzi G.B., D'ardes D., Donati K.G., Di Gennaro F., Di Tano G., D'offizi G., Filippini T., Fusco F.M., Gaudiosi C., Gentile I., Gini G., Grandone E., Guarnieri G., Lamanna G.L.F., Larizza G., Leone A., Lio V., Losito A.R., Maccagni G., Maitan S., Mancarella S., Manuele R., Mapelli M., Maragna R., Marra L., Maresca G., Marotta C., Mastroianni F., Mazzitelli M., Mengozzi A., Menichetti F., Milic J., Minutolo F., Molena B., Mussinelli R., Mussini C., Musso M., Odone A., Olivieri M., Pasi E., Perroni A., Petri F., Pinchera B., Pivato C.A., Poletti V., Ravaglia C., Rossato M., Rossi M., Sabena A., Salinaro F., Sangiovanni V., Sanrocco C., Scorzolini L., Sgariglia R., Simeone P.G., Spinicci M., Trecarichi E.M., Veronesi G., Vettor R., Vianello A., Vinceti M., Visconti E., Vocciante L., Caterina R.D., and Iacoviello L.

Subjects
Medicine (General), medicine.medical_specialty, Lopinavir/ritonavir, Lopinavir, R5-920, Internal medicine, medicine, Darunavir, Original Research, COVID-19, In-hospital mortality, SARS-CoV-2, darunavir, in-hospital mortality, lopinavir, business.industry, Cobicistat, Mortality rate, General Medicine, medicine.disease, Propensity score matching, Medicine, Ritonavir, business, medicine.drug, Kidney disease
Abstract

Background: Protease inhibitors have been considered as possible therapeutic agents for COVID-19 patients.Objectives: To describe the association between lopinavir/ritonavir (LPV/r) or darunavir/cobicistat (DRV/c) use and in-hospital mortality in COVID-19 patients.Study Design: Multicenter observational study of COVID-19 patients admitted in 33 Italian hospitals. Medications, preexisting conditions, clinical measures, and outcomes were extracted from medical records. Patients were retrospectively divided in three groups, according to use of LPV/r, DRV/c or none of them. Primary outcome in a time-to event analysis was death. We used Cox proportional-hazards models with inverse probability of treatment weighting by multinomial propensity scores.Results: Out of 3,451 patients, 33.3% LPV/r and 13.9% received DRV/c. Patients receiving LPV/r or DRV/c were more likely younger, men, had higher C-reactive protein levels while less likely had hypertension, cardiovascular, pulmonary or kidney disease. After adjustment for propensity scores, LPV/r use was not associated with mortality (HR = 0.94, 95% CI 0.78 to 1.13), whereas treatment with DRV/c was associated with a higher death risk (HR = 1.89, 1.53 to 2.34, E-value = 2.43). This increased risk was more marked in women, in elderly, in patients with higher severity of COVID-19 and in patients receiving other COVID-19 drugs.Conclusions: In a large cohort of Italian patients hospitalized for COVID-19 in a real-life setting, the use of LPV/r treatment did not change death rate, while DRV/c was associated with increased mortality. Within the limits of an observational study, these data do not support the use of LPV/r or DRV/c in COVID-19 patients.

Published
2021

17. Ceftazidime-avibactam use for klebsiella pneumoniae carbapenemase-producing k. pneumoniae infections: A retrospective observational multicenter study

Author

Mirko Compagno, Giampaolo Corti, Maddalena Peghin, Francesca Raffaelli, Annalisa Saracino, Cristina Mussini, Spinello Antinori, Maddalena Giannella, Roberto Cauda, Marianna Rossi, Gennaro De Pascale, Elena Guffanti, Enrico Maria Trecarichi, Giancarlo Ceccarelli, Teresa Spanu, Elisabetta Mantengoli, Antonio Cascio, Mario Venditti, Loredana Sarmati, Carlo Tascini, Silvia Corcione, Daniele Roberto Giacobbe, Massimo Fantoni, Linda Bussini, Paolo Bonfanti, Alessandra Mularoni, Marianna Meschiari, Nour Shbaklo, Giusy Tiseo, Mario Tumbarello, Roberto Luzzati, Angela Raffaella Losito, Alessandra Oliva, Pierluigi Viale, Alessandro Russo, Francesco Giuseppe De Rosa, Gaetano Brindicci, Ivan Gentile, Alberto Corona, Andrea De Gasperi, Paolo Grossi, Marco Falcone, Alessandro Capone, Cristina Rovelli, Matteo Bassetti, Tumbarello M., Raffaelli F., Giannella M., Mantengoli E., Mularoni A., Venditti M., De Rosa F.G., Sarmati L., Bassetti M., Brindicci G., Rossi M., Luzzati R., Grossi P.A., Corona A., Capone A., Falcone M., Mussini C., Trecarichi E.M., Cascio A., Guffanti E., Russo A., De Pascale G., Tascini C., Gentile I., Losito A.R., Bussini L., Corti G., Ceccarelli G., Corcione S., Compagno M., Giacobbe D.R., Saracino A., Fantoni M., Antinori S., Peghin M., Bonfanti P., Oliva A., De Gasperi A., Tiseo G., Rovelli C., Meschiari M., Shbaklo N., Spanu T., Cauda R., Viale P., Tumbarello, Mario, Raffaelli, Francesca, Giannella, Maddalena, Mantengoli, Elisabetta, Mularoni, Alessandra, Venditti, Mario, De Rosa, Francesco Giuseppe, Sarmati, Loredana, Bassetti, Matteo, Brindicci, Gaetano, Rossi, Marianna, Luzzati, Roberto, Grossi, Paolo Antonio, Corona, Alberto, Capone, Alessandro, Falcone, Marco, Mussini, Cristina, Trecarichi, Enrico Maria, Cascio, Antonio, Guffanti, Elena, Russo, Alessandro, De Pascale, Gennaro, Tascini, Carlo, Gentile, Ivan, Losito, Angela Raffaella, Bussini, Linda, Conti, Giampaolo, Ceccarelli, Giancarlo, Corcione, Silvia, Compagno, Mirko, Giacobbe, Daniele Roberto, Saracino, Annalisa, Fantoni, Massimo, Antinori, Spinello, Peghin, Maddalena, Bonfanti, Paolo, Oliva, Alessandra, De Gasperi, Andrea, Tiseo, Giusy, Rovelli, Cristina, Meschiari, Marianna, Shbaklo, Nour, Spanu, Teresa, Cauda, Roberto, and Viale, Pierluigi

Subjects
Microbiology (medical), Adult, medicine.medical_specialty, Azabicyclo Compound, carbapenemases, Bacterial Protein, Microbial Sensitivity Tests, Neutropenia, Ceftazidime, beta-Lactamases, beta-Lactamase, Carbapenemase, carbapenemase, Bacterial Proteins, Retrospective Studie, Lower respiratory tract infection, Internal medicine, Drug Combination, Anti-Bacterial Agent, medicine, Humans, KPC-producing Klebsiella pneumoniae, Retrospective Studies, Septic shock, business.industry, Ceftazidime-avibactam, Microbial Sensitivity Test, ceftazidime-avibactam, Mortality rate, Carbapenemases, Anti-Bacterial Agents, Azabicyclo Compounds, Drug Combinations, Klebsiella Infections, Klebsiella pneumoniae, medicine.disease, Ceftazidime/avibactam, Settore MED/17, Infectious Diseases, Cohort, Propensity score matching, Observational study, business, medicine.drug, Human, Klebsiella Infection
Abstract

Background A growing body of observational evidence supports the value of ceftazidime-avibactam (CAZ-AVI) in managing infections caused by carbapenem-resistant Enterobacteriaceae. Methods We retrospectively analyzed observational data on use and outcomes of CAZ-AVI therapy for infections caused by Klebsiella pneumoniae carbapenemase–producing K. pneumoniae (KPC-Kp) strains. Multivariate regression analysis was used to identify variables independently associated with 30-day mortality. Results were adjusted for propensity score for receipt of CAZ-AVI combination regimens versus CAZ-AVI monotherapy. Results The cohort comprised 577 adults with bloodstream infections (n = 391) or nonbacteremic infections involving mainly the urinary tract, lower respiratory tract, and intra-abdominal structures. All received treatment with CAZ-AVI alone (n = 165) or with ≥1 other active antimicrobials (n = 412). The all-cause mortality rate 30 days after infection onset was 25% (146/577). There was no significant difference in mortality between patients managed with CAZ-AVI alone and those treated with combination regimens (26.1% vs 25.0%, P = .79). In multivariate analysis, mortality was positively associated with presence at infection onset of septic shock (P = .002), neutropenia (P < .001), or an INCREMENT score ≥8 (P = .01); with lower respiratory tract infection (LRTI) (P = .04); and with CAZ-AVI dose adjustment for renal function (P = .01). Mortality was negatively associated with CAZ-AVI administration by prolonged infusion (P = .006). All associations remained significant after propensity score adjustment. Conclusions CAZ-AVI is an important option for treating serious KPC-Kp infections, even when used alone. Further study is needed to explore the drug’s seemingly more limited efficacy in LRTIs and potential survival benefits of prolonging CAZ-AVI infusions to ≥3 hours.

Published
2021

18. The need to continue testing for HIV, even during the coronavirus disease 2019 (COVID-19) pandemic

Author

Enrica Tamburrini, A Dusina, S Di Giambenedetto, Francesco Vladimiro Segala, Arturo Ciccullo, Roberto Cauda, Alberto Borghetti, and Elena Visconti

Subjects
Adult, Male, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Fever, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Human immunodeficiency virus (HIV), Lymphadenopathy, testing HIV, HIV Infections, medicine.disease_cause, Settore MED/17 - MALATTIE INFETTIVE, Young Adult, Pandemic, medicine, Humans, Pharmacology (medical), Pandemics, business.industry, SARS-CoV-2, Health Policy, COVID-19, HIV, Virology, Thrombocytopenia, Infectious Diseases, business
Published
2021

19. Low Dose Hydroxychloroquine is Associated with Lower Mortality in COVID-19: A Meta-Analysis of 27 Studies and 44,684 Patients

Author

Roberto Cauda, Licia Iacoviello, Antonio Cassone, Simona Costanzo, Giovanni de Gaetano, and Augusto Di Castelnuovo

Subjects
medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), business.industry, Meta-analysis, Internal medicine, Low dose, Medicine, Hydroxychloroquine, business, Lower mortality, Gastroenterology, medicine.drug
Abstract

Background: Hydroxychloroquine (HCQ) was proposed as potential treatment for COVID-19, but its association with mortality is not well characterized. We conducted two meta-analyses to evaluate the association between HCQ (with or without azithromycin (AZM)) and total mortality in COVID-19 patients.Methods: Articles were retrieved until November 10th, 2020 by searching in seven databases. Data were combined using the general variance-based method.Results: A total of 27 articles were found (N=44,684 patients, including N=7,803 from 5 randomized clinical trials (RCTs)). Overall, the use of HCQ was associated with 22% lower mortality risk (pooled risk ratio: 0.78, 95%CI: 0.67 to 0.91; I2=80%, random effects). This association was found reversed when pooling only RCTs (16.7% of the overall weight; pooled risk ratio: 1.11, 0.99 to 1.24) or studies in which daily dose >400 mg or total dose >4,400 mg were used (pooled risk ratio: 1.10, 95%CI: 0.99 to 1.23 in both cases). Overall, HCQ+AZM (10 studies) was also associated with 28% lower mortality risk, but uncertainty was large (95%CI: 0.48 to 1.08; P=0.11). Use of HCQ was not associated with severe adverse events.Conclusions: HCQ use was not associated with mortality reduction in COVID-19 patients when 5 RCTs only were evaluated, while a 9% to 33% reduced mortality was observed when observational studies were also included. The association was mainly apparent in studies that used lower doses of HCQ. These findings can help disentangling the debate on HCQ use in COVID-19.

Published
2020

20. No evidence of SARS-CoV-2 circulation in HIV-infected patients between December 2019 and February 2020 in Rome, Italy

Author

Simona Di Giambenedetto, Roberto Cauda, Francesca Lombardi, Simone Belmonti, Massimiliano Fabbiani, Rosalba Ricci, Arturo Ciccullo, and Alberto Borghetti

Subjects
Microbiology (medical), 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), HIV, General Medicine, Settore MED/17 - MALATTIE INFETTIVE, Virology, Infectious Diseases, Hiv infected patients, Medicine, business, Letter to the Editor, COVID
Published
2020

21. Low dose hydroxychloroquine is associated with lower mortality in COVID-19: a meta-analysis of 26 studies and 44,521 patients

Author

Antonio Cassone, Licia Iacoviello, de Gaetano G, Di Castelnuovo A, Roberto Cauda, and S. Costanzo

Subjects
medicine.medical_specialty, business.industry, Hydroxychloroquine, Random effects model, Azithromycin, law.invention, Clinical trial, Randomized controlled trial, law, Internal medicine, Relative risk, Meta-analysis, medicine, Observational study, business, medicine.drug
Abstract

BackgroundHydroxychloroquine (HCQ) was proposed as potential treatment for COVID-19, but its association with mortality is not well characterized. We conducted two meta-analyses to evaluate the association between HCQ (with or without azithromycin (AZM)) and total mortality in COVID-19 patients.MethodsArticles were retrieved until October 20th, 2020 by searching in seven databases. Data were combined using the general variance-based method on relative risk estimates.ResultsA total of 26 articles were found (N=44,521 COVID-19 patients, including N=7,324 from 4 randomized clinical trials (RCTs)); 10 studies were valuable for analysing the association of HCQ+AZM. Overall, the use of HCQ was associated with 21% lower mortality risk (pooled risk ratio: 0.79, 95%CI: 0.67 to 0.93; high level of heterogeneity: I2=82%, random effects). This association vanished (1.10, 95%CI: 0.99 to 1.23 and 1.10, 95%CI: 0.99 to 1.23) when daily dose >400 mg or total dose >4,400 mg were used, respectively). HCQ+AZM was also associated with 25% lower mortality risk, but uncertainty was large (95%CI: 0.50 to 1.13; P=0.17). No association was apparent when only pooling the 4 RCTs (13.8% of the overall weight; pooled risk ratio: 1.11, 95%CI: 0.99 to 1.24).ConclusionsHCQ use was not associated with either increased or decreased mortality in COVID-19 patients when 4 RCTs only were evaluated, while a 7% to 33% reduced mortality was observed when observational studies were also included. The association was mainly apparent when pooling studies using lower doses of HCQ. These findings can help disentangling the debate on HCQ use in COVID-19.Key-pointsLow dose hydroxychloroquine was associated with reduced mortality in COVID-19 patients, as seen in observational studies but not in randomised clinical trials, which used high doses of hydroxychloroquine. These findings can help disentangling the debate on hydroxychloroquine use in COVID-19.

Published
2020

22. Predictors of mortality among adult, old and the oldest old patients with bloodstream infections: An age comparison

Author

Brunella Posteraro, Massimo Fantoni, Roberto Cauda, Claudia Palazzolo, Graziano Onder, Marta Camici, Teresa Spanu, Rita Murri, Francesco Taccari, Maurizio Sanguinetti, and Francesca Giovannenze

Subjects
Adult, Methicillin-Resistant Staphylococcus aureus, Pediatrics, medicine.medical_specialty, Bacteremia, 030204 cardiovascular system & hematology, Group A, Settore MED/07 - MICROBIOLOGIA E MICROBIOLOGIA CLINICA, Oldest old, 03 medical and health sciences, Elderly, 0302 clinical medicine, Primary outcome, Risk Factors, Sepsis, Internal Medicine, Enterococcus spp, Medicine, Humans, 030212 general & internal medicine, Mortality, Aged, Retrospective Studies, Aged, 80 and over, Cross Infection, business.industry, Retrospective cohort study, Length of Stay, Staphylococcal Infections, University hospital, Anti-Bacterial Agents, Single centre, Bloodstream infections, business, Hospital stay
Abstract

Bloodstream infections (BSIs) are a major cause of mortality in elderly. Objective of the study is to identify factors predictive of mortality in old and oldest old patients.This is a single centre retrospective observational study, including all patients admitted to Fondazione Policlinico A. Gemelli university hospital and diagnosed with BSI. Patients were stratified into three groups according to age: adult (A), younger than 65; old (O), aged between 65 and 80; oldest old (OO), older than 80. Primary outcome was 30-day in-hospital mortality. Secondary outcomes were duration of antimicrobial therapy (DOT) and length of hospital stay (LOS).Of the 1034 patients included in the study, 346 were in group A, 447 in group O and 241 in group OO. The rate of 30-day mortality raised from 6.9% (24/346) in group A to 10.8% (84/447) in group O and 33.2% (80/241) in group OO (p0.01), while DOT and LOS significantly decreased moving from adults to oldest old (p0.01). Methicillin-resistant Staphylococcus aureus (MRSA) and Enterococcus spp were both independently correlated to an increased 30-day mortality risk selectively in patients older than 80 (MRSA: HR 2.37, p=0.03; Enterococcus spp: HR 2.44, p=0.01).BSIs have a high impact on survival in old and oldest old patients. BSIs by gram-positive pathogens, in particular MRSA and Enterococcus spp, should be a wake-up call for physicians, who should focus efforts on adequate and prompt antibiotic and support treatment.

Published
2020

23. Antibiotic Appropriateness and Adherence to Local Guidelines in Perioperative Prophylaxis: Results from an Antimicrobial Stewardship Intervention

Author

Pierluigi Del Vecchio, Massimo Fantoni, Roberto Cauda, Emanuela Birocchi, Francesca Giovannenze, Francesco Taccari, Eleonora Taddei, Rita Murri, and Francesco Vladimiro Segala

Subjects
Adult, Male, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, genetic structures, Antibiotic resistance, Operative Time, 030106 microbiology, Psychological intervention, Drug resistance, Settore MED/17 - MALATTIE INFETTIVE, lcsh:Infectious and parasitic diseases, Hospitals, University, Antimicrobial Stewardship, 03 medical and health sciences, Surgical prophylaxis, Drug Utilization Review, 0302 clinical medicine, Humans, Surgical Wound Infection, Medicine, Antimicrobial stewardship, Pharmacology (medical), lcsh:RC109-216, 030212 general & internal medicine, Dosing, Antibiotic prophylaxis, Aged, Antibiotic stewardship, business.industry, Research, Incidence (epidemiology), Public Health, Environmental and Occupational Health, Drug Resistance, Microbial, Perioperative, Antibiotic Prophylaxis, Length of Stay, Middle Aged, Surgical-site infection, Infectious Diseases, Italy, Emergency medicine, Female, Guideline Adherence, business
Abstract

Objectives Surgical antibiotic prophylaxis (SAP) represents a major indication of antibiotic consumption worldwide. The present study aims to report the results of an enabling, long-term AMS intervention conducted between 2013 and 2019 on an Italian University Hospital performing more than 40.000 surgical interventions per year. Methods SAP inappropriateness was defined according to the ASHP guidelines and divided in four main categories: indication, selection and dosing, duration, timing. Between 2013 and 2019, we conducted a continuative AMS intervention over 14 surgical departments that included enablement, review of selected clinical records and feedback. Results We collected a total of 789 SAP prescribed to 735 patients (mean age 56.7 ± 17.8y). Overall, guideline adherence improved from 36.6% (n = 149) at baseline to 57.9% (n = 221) post-intervention (P P indication (from 58.5 to 93.2%), selection and dosing (from 58.5 to 80.6%), timing (from 92.4 to 97.6%), duration (from 71 to 80.1%). Conclusions Though results cannot be generalized to all hospital populations, enabling AMS interventions may be effective in establishing a sustained improvement in SAP appropriateness rates. Once identified the main causes of SAP inappropriateness, tailored AMS interventions for each department may be beneficial. Further studies are needed to evaluate specific outcomes as incidence of surgical site infections and antimicrobial resistance.

Published
2020

24. Common cardiovascular risk factors and in-hospital mortality in 3,894 patients with COVID-19: survival analysis and machine learning-based findings from the multicentre Italian CORIST Study

Author

Augusto Di Castelnuovo, Marialaura Bonaccio, Simona Costanzo, Alessandro Gialluisi, Andrea Antinori, Nausicaa Berselli, Lorenzo Blandi, Raffaele Bruno, Roberto Cauda, Giovanni Guaraldi, Ilaria My, Lorenzo Menicanti, Giustino Parruti, Giuseppe Patti, Stefano Perlini, Francesca Santilli, Carlo Signorelli, Giulio G. Stefanini, Alessandra Vergori, Amina Abdeddaim, Walter Ageno, Antonella Agodi, Piergiuseppe Agostoni, Luca Aiello, Samir Al Moghazi, Filippo Aucella, Greta Barbieri, Alessandro Bartoloni, Carolina Bologna, Paolo Bonfanti, Serena Brancati, Francesco Cacciatore, Lucia Caiano, Francesco Cannata, Laura Carrozzi, Antonio Cascio, Antonella Cingolani, Francesco Cipollone, Claudia Colomba, Annalisa Crisetti, Francesca Crosta, Gian B. Danzi, Damiano D'Ardes, Katleen de Gaetano Donati, Francesco Di Gennaro, Gisella Di Palma, Giuseppe Di Tano, Massimo Fantoni, Tommaso Filippini, Paola Fioretto, Francesco M. Fusco, Ivan Gentile, Leonardo Grisafi, Gabriella Guarnieri, Francesco Landi, Giovanni Larizza, Armando Leone, Gloria Maccagni, Sandro Maccarella, Massimo Mapelli, Riccardo Maragna, Rossella Marcucci, Giulio Maresca, Claudia Marotta, Lorenzo Marra, Franco Mastroianni, Alessandro Mengozzi, Francesco Menichetti, Jovana Milic, Rita Murri, Arturo Montineri, Roberta Mussinelli, Cristina Mussini, Maria Musso, Anna Odone, Marco Olivieri, Emanuela Pasi, Francesco Petri, Biagio Pinchera, Carlo A. Pivato, Roberto Pizzi, Venerino Poletti, Francesca Raffaelli, Claudia Ravaglia, Giulia Righetti, Andrea Rognoni, Marco Rossato, Marianna Rossi, Anna Sabena, Francesco Salinaro, Vincenzo Sangiovanni, Carlo Sanrocco, Antonio Scarafino, Laura Scorzolini, Raffaella Sgariglia, Paola G. Simeone, Enrico Spinoni, Carlo Torti, Enrico M. Trecarichi, Francesca Vezzani, Giovanni Veronesi, Roberto Vettor, Andrea Vianello, Marco Vinceti, Raffaele De Caterina, Licia Iacoviello, Di Castelnuovo, A., Bonaccio, M., Costanzo, S., Gialluisi, A., Antinori, A., Berselli, N., Blandi, L., Bruno, R., Cauda, R., Guaraldi, G., My, I., Menicanti, L., Parruti, G., Patti, G., Perlini, S., Santilli, F., Signorelli, C., Stefanini, G. G., Vergori, A., Abdeddaim, A., Ageno, W., Agodi, A., Agostoni, P., Aiello, L., Al Moghazi, S., Aucella, F., Barbieri, G., Bartoloni, A., Bologna, C., Bonfanti, P., Brancati, S., Cacciatore, F., Caiano, L., Cannata, F., Carrozzi, L., Cascio, A., Cingolani, A., Cipollone, F., Colomba, C., Crisetti, A., Crosta, F., Danzi, G. B., D'Ardes, D., de Gaetano Donati, K., Di Gennaro, F., Di Palma, G., Di Tano, G., Fantoni, M., Filippini, T., Fioretto, P., Fusco, F. M., Gentile, I., Grisafi, L., Guarnieri, G., Landi, F., Larizza, G., Leone, A., Maccagni, G., Maccarella, S., Mapelli, M., Maragna, R., Marcucci, R., Maresca, G., Marotta, C., Marra, L., Mastroianni, F., Mengozzi, A., Menichetti, F., Milic, J., Murri, R., Montineri, A., Mussinelli, R., Mussini, C., Musso, M., Odone, A., Olivieri, M., Pasi, E., Petri, F., Pinchera, B., Pivato, C. A., Pizzi, R., Poletti, V., Raffaelli, F., Ravaglia, C., Righetti, G., Rognoni, A., Rossato, M., Rossi, M., Sabena, A., Salinaro, F., Sangiovanni, V., Sanrocco, C., Scarafino, A., Scorzolini, L., Sgariglia, R., Simeone, P. G., Spinoni, E., Torti, C., Trecarichi, E. M., Vezzani, F., Veronesi, G., Vettor, R., Vianello, A., Vinceti, M., De Caterina, R., Iacoviello, L., Di Castelnuovo, Augusto, Bonaccio, Marialaura, Costanzo, Simona, Gialluisi, Alessandro, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bruno, Raffaele, Cauda, Roberto, Guaraldi, Giovanni, My, Ilaria, Menicanti, Lorenzo, Parruti, Giustino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G, Vergori, Alessandra, Abdeddaim, Amina, Ageno, Walter, Agodi, Antonella, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Aucella, Filippo, Barbieri, Greta, Bartoloni, Alessandro, Bologna, Carolina, Bonfanti, Paolo, Brancati, Serena, Cacciatore, Francesco, Caiano, Lucia, Cannata, Francesco, Carrozzi, Laura, Cascio, Antonio, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Crisetti, Annalisa, Crosta, Francesca, Danzi, Gian B, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Palma, Gisella, Di Tano, Giuseppe, Fantoni, Massimo, Filippini, Tommaso, Fioretto, Paola, Fusco, Francesco M, Gentile, Ivan, Grisafi, Leonardo, Guarnieri, Gabriella, Landi, Francesco, Larizza, Giovanni, Leone, Armando, Maccagni, Gloria, Maccarella, Sandro, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mengozzi, Alessandro, Menichetti, Francesco, Milic, Jovana, Murri, Rita, Montineri, Arturo, Mussinelli, Roberta, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Pasi, Emanuela, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A, Pizzi, Roberto, Poletti, Venerino, Raffaelli, Francesca, Ravaglia, Claudia, Righetti, Giulia, Rognoni, Andrea, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scarafino, Antonio, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola G, Spinoni, Enrico, Torti, Carlo, Trecarichi, Enrico M, Vezzani, Francesca, Veronesi, Giovanni, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo, A, Bonaccio, M, Costanzo, S, Gialluisi, A, Antinori, A, Berselli, N, Blandi, L, Bruno, R, Cauda, R, Guaraldi, G, My, I, Menicanti, L, Parruti, A, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Abdeddaim, A, Ageno, W, Agodi, A, Agostoni, P, Aiello, L, Al Moghazi, S, Aucella, F, Barbieri, G, Bartoloni, A, Bologna, C, Bonfanti, P, Brancati, S, Cacciatore, F, Caiano, L, Cannata, F, Carrozzi, L, Cascio, A, Cingolani, A, Cipollone, F, Colomba, C, Crisetti, A, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Palma, G, Di Tano, G, Fantoni, M, Filippini, T, Fioretto, P, Fusco, F, Gentile, I, Grisafi, L, Guarnieri, G, Landi, F, Larizza, G, Leone, A, Maccagni, G, Maccarella, S, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marotta, C, Marra, L, Mastroianni, F, Mengozzi, A, Menichetti, F, Milic, J, Miurri, R, Montineri, A, Mussinelli, R, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Petri, F, Pinchera, B, Pivato, C, Pizzi, R, Poletti, V, Raffaelli, F, Ravaglia, C, Righetti, G, Rognoni, A, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scarafino, A, Scorzolini, L, Sgariglia, R, Simeone, P, Spinoni, E, Torti, C, Trecarichi, E, Vezzani, F, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, De Caterina, R, and Iacoviello, L

Subjects
Male, Epidemiology, Endocrinology, Diabetes and Metabolism, Medicine (miscellaneous), 030204 cardiovascular system & hematology, computer.software_genre, Machine Learning, 0302 clinical medicine, Retrospective Studie, Risk Factors, Cardiovascular Disease, 80 and over, Medicine, Age Factor, Viral, Hospital Mortality, Betacoronavirus Hospital Mortality, Young adult, Aged, 80 and over, Nutrition and Dietetics, COVID-19, In-hospital mortality, Risk factors, Mortality rate, Hazard ratio, Age Factors, Middle Aged, C-Reactive Protein, Cardiovascular Diseases, Female, Survival Analysi, Cardiology and Cardiovascular Medicine, Coronavirus Infections, Human, Glomerular Filtration Rate, Adult, medicine.medical_specialty, Adolescent, Pneumonia, Viral, 030209 endocrinology & metabolism, Settore MED/17 - MALATTIE INFETTIVE, Machine learning, Aged, Humans, Pandemics, Retrospective Studies, SARS-CoV-2, Survival Analysis, Young Adult, Betacoronavirus, Article, 03 medical and health sciences, Risk factor, Survival analysis, Pandemic, Betacoronaviru, business.industry, Coronavirus Infection, Risk Factor, Retrospective cohort study, Pneumonia, Confidence interval, Artificial intelligence, business, computer
Abstract

Background and aims There is poor knowledge on characteristics, comorbidities and laboratory measures associated with risk for adverse outcomes and in-hospital mortality in European Countries. We aimed at identifying baseline characteristics predisposing COVID-19 patients to in-hospital death. Methods and results Retrospective observational study on 3894 patients with SARS-CoV-2 infection hospitalized from February 19th to May 23rd, 2020 and recruited in 30 clinical centres distributed throughout Italy. Machine learning (random forest)-based and Cox survival analysis. 61.7% of participants were men (median age 67 years), followed up for a median of 13 days. In-hospital mortality exhibited a geographical gradient, Northern Italian regions featuring more than twofold higher death rates as compared to Central/Southern areas (15.6% vs 6.4%, respectively). Machine learning analysis revealed that the most important features in death classification were impaired renal function, elevated C reactive protein and advanced age. These findings were confirmed by multivariable Cox survival analysis (hazard ratio (HR): 8.2; 95% confidence interval (CI) 4.6–14.7 for age ≥85 vs 18–44 y); HR = 4.7; 2.9–7.7 for estimated glomerular filtration rate levels, Highlights • Impaired renal function, elevated C-reactive protein and advanced age were major indicators of death in COVID-19 patients. • These associations were substantially homogenous across all sub-groups analysed. • No relation was found with obesity, tobacco use, cardiovascular disease and related-comorbidities. • Death rates were higher in the Northern as opposed to Central-Southern Italian regions.

Published
2020

25. Off‐label use of tocilizumab in patients with SARS‐CoV‐2 infection

Author

Antonio Gasbarrini, Alberto Borghetti, Enrica Tamburrini, Giovanni Gambassi, Roberto Bernabei, Simona Di Giambenedetto, Roberto Cauda, Arturo Ciccullo, Francesco Landi, Lorenzo Zileri Dal Verme, and Elena Visconti

Subjects
2019-20 coronavirus outbreak, medicine.medical_specialty, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Settore MED/17 - MALATTIE INFETTIVE, Antibodies, Monoclonal, Humanized, medicine.disease_cause, Off-label use, Antibodies, tocilizumab, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Tocilizumab, COVID‐19, Virology, Monoclonal, Pandemic, medicine, Humans, pneumonia, In patient, 030212 general & internal medicine, skin and connective tissue diseases, Intensive care medicine, Humanized, Pandemics, Letter to the Editor, Coronavirus, interstitial pneumonia, SARS-CoV-2, business.industry, COVID-19, Off-Label Use, Receptor antibody, COVID-19 Drug Treatment, Infectious Diseases, chemistry, subcutaneous, 030211 gastroenterology & hepatology, business, SARS‐COV‐2
Abstract

Over the last months, pandemic SARS‐CoV‐2 caused a significant challenge for clinicians. Unfortunately, no approved and validated treatments are available. Intravenous tocilizumab, an antirheumatic drug, seems to be promising in counteracting cytokine storm caused by SARS‐CoV‐2 infection with associated clinical improvements. We report herein a case series of patients with COVID‐19 pneumonia who were treated with tocilizumab administrated, for the first time, subcutaneously with good clinical and radiological outcomes. This article is protected by copyright. All rights reserved.

Published
2020
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26. Use of hydroxychloroquine in hospitalised COVID-19 patients is associated with reduced mortality: Findings from the observational multicentre Italian CORIST study

Author

Venerino Poletti, Damiano D'Ardes, Paola Simeone, Cristina Mussini, Giustino Parruti, Sandro Maccarella, Licia Iacoviello, Giulio G. Stefanini, Roberta Mussinelli, Vincenzo Sangiovanni, Paolo Bonfanti, Roberto Vettor, Andrea Vianello, Arturo Montineri, Roberto Cauda, Elvira Grandone, Maria Mazzitelli, Claudia Ravaglia, Marialaura Bonaccio, Giulio Maresca, Francesco Di Gennaro, Alessandro Mengozzi, Anna Sabena, Gian Battista Danzi, Giuseppe Di Tano, Emanuela Pasi, Ilaria Rossi, Lucia Caiano, Laura Carrozzi, Francesco Landi, Francesca Crosta, Tommaso Filippini, Francesco Menichetti, Piergiuseppe Agostoni, Andrea Madaro, Antonio Cascio, Carlo Signorelli, Michele Spinicci, Carlo Sanrocco, Enrico Guido Spinoni, Maria Musso, Alessandra Vergori, Lorenzo Marra, Giuseppe Patti, Laura Vocciante, Marco Olivieri, Francesca Santilli, Stefano Perlini, Claudia Colomba, Francesco Salinaro, Marianna Meschiari, Gabriella Guarnieri, Giampiero D'Offizi, Riccardo Maragna, Paola Del Giacomo, Giancarlo Gini, Katleen de Gaetano Donati, Andrea Antinori, Filippo Aucella, Raffaele De Caterina, Lorenzo Menicanti, Gloria Maccagni, Amedeo Venezia, Chiara Dal Pra, Carlo Andrea Pivato, Walter Ageno, Antonella Agodi, Francesco Cannata, Francesco Petri, Luca Aiello, Biagio Pinchera, Marinella Astuto, Raffaella Sgariglia, Giovanni Guaraldi, Marco Vinceti, Laura Scorzolini, Samir Al Moghazi, Armando Leone, Giovanni Veronesi, Arturo Ciccullo, Leonardo Grisafi, Francesco Cipollone, Massimo Mapelli, Greta Barbieri, Silvia Lamonica, Raffaele Bruno, Filippo Minutolo, Antonella Cingolani, Alessandro Gialluisi, Marco Rossato, Andrea Rognoni, Marianna Rossi, Claudia Marotta, Franco Mastroianni, Ilaria My, Enrico Maria Trecarichi, Anna Odone, Alessandro Bartoloni, Simona Costanzo, Francesco Cacciatore, Ivan Gentile, Massimo Rinaldi, Nausicaa Berselli, Francesco Maria Fusco, Augusto Di Castelnuovo, Lorenzo Blandi, Castelnuovo A.D., Costanzo S., Antinori A., Berselli N., Blandi L., Bruno R., Cauda R., Guaraldi G., Menicanti L., My I., Parruti G., Patti G., Perlini S., Santilli F., Signorelli C., Spinoni E., Stefanini G.G., Vergori A., Ageno W., Agodi A., Aiello L., Agostoni P., Moghazi S.A., Astuto M., Aucella F., Barbieri G., Bartoloni A., Bonaccio M., Bonfanti P., Cacciatore F., Caiano L., Cannata F., Carrozzi L., Cascio A., Ciccullo A., Cingolani A., Cipollone F., Colomba C., Crosta F., Pra C.D., Danzi G.B., D'Ardes D., Donati K.D.G., Giacomo P.D., Gennaro F.D., Di Tano G., D'Offizi G., Filippini T., Fusco F.M., Gentile I., Gialluisi A., Gini G., Grandone E., Grisafi L., Guarnieri G., Lamonica S., Landi F., Leone A., Maccagni G., Maccarella S., Madaro A., Mapelli M., Maragna R., Marra L., Maresca G., Marotta C., Mastroianni F., Mazzitelli M., Mengozzi A., Menichetti F., Meschiari M., Minutolo F., Montineri A., Mussinelli R., Mussini C., Musso M., Odone A., Olivieri M., Pasi E., Petri F., Pinchera B., Pivato C.A., Poletti V., Ravaglia C., Rinaldi M., Rognoni A., Rossato M., Rossi I., Rossi M., Sabena A., Salinaro F., Sangiovanni V., Sanrocco C., Scorzolini L., Sgariglia R., Simeone P.G., Spinicci M., Trecarichi E.M., Venezia A., Veronesi G., Vettor R., Vianello A., Vinceti M., Vocciante L., De Caterina R., Iacoviello L., Castelnuovo, A. D., Costanzo, S., Antinori, A., Berselli, N., Blandi, L., Bruno, R., Cauda, R., Guaraldi, G., Menicanti, L., My, I., Parruti, G., Patti, G., Perlini, S., Santilli, F., Signorelli, C., Spinoni, E., Stefanini, G. G., Vergori, A., Ageno, W., Agodi, A., Aiello, L., Agostoni, P., Moghazi, S. A., Astuto, M., Aucella, F., Barbieri, G., Bartoloni, A., Bonaccio, M., Bonfanti, P., Cacciatore, F., Caiano, L., Cannata, F., Carrozzi, L., Cascio, A., Ciccullo, A., Cingolani, A., Cipollone, F., Colomba, C., Crosta, F., Pra, C. D., Danzi, G. B., D'Ardes, D., Donati, K. D. G., Giacomo, P. D., Gennaro, F. D., Di Tano, G., D'Offizi, G., Filippini, T., Fusco, F. M., Gentile, I., Gialluisi, A., Gini, G., Grandone, E., Grisafi, L., Guarnieri, G., Lamonica, S., Landi, F., Leone, A., Maccagni, G., Maccarella, S., Madaro, A., Mapelli, M., Maragna, R., Marra, L., Maresca, G., Marotta, C., Mastroianni, F., Mazzitelli, M., Mengozzi, A., Menichetti, F., Meschiari, M., Minutolo, F., Montineri, A., Mussinelli, R., Mussini, C., Musso, M., Odone, A., Olivieri, M., Pasi, E., Petri, F., Pinchera, B., Pivato, C. A., Poletti, V., Ravaglia, C., Rinaldi, M., Rognoni, A., Rossato, M., Rossi, I., Rossi, M., Sabena, A., Salinaro, F., Sangiovanni, V., Sanrocco, C., Scorzolini, L., Sgariglia, R., Simeone, P. G., Spinicci, M., Trecarichi, E. M., Venezia, A., Veronesi, G., Vettor, R., Vianello, A., Vinceti, M., Vocciante, L., De Caterina, R., Iacoviello, L., Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bruno, R, Cauda, R, Guaraldi, G, Menicanti, L, My, I, Parruti, G, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Spinoni, E, Stefanini, G, Vergori, A, Ageno, W, Agodi, A, Aiello, L, Agostoni, P, Moghazi, S, Astuto, M, Aucella, F, Barbieri, G, Bartoloni, A, Bonaccio, M, Bonfanti, P, Cacciatore, F, Caiano, L, Cannata, F, Carrozzi, L, Cascio, A, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Crosta, F, Pra, C, Danzi, G, D'Ardes, D, Donati, K, Giacomo, P, Gennaro, F, Tano, G, D'Offizi, G, Filippini, T, Fusco, F, Gentile, I, Gialluisi, A, Gini, G, Grandone, E, Grisafi, L, Guarnieri, G, Lamonica, S, Landi, F, Leone, A, Maccagni, G, Maccarella, S, Madaro, A, Mapelli, M, Maragna, R, Marra, L, Maresca, G, Marotta, C, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Minutolo, F, Montineri, A, Mussinelli, R, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rinaldi, M, Rognoni, A, Rossato, M, Rossi, I, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Spinicci, M, Trecarichi, E, Venezia, A, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, Vocciante, L, De Caterina, R, and Iacoviello, L

Subjects
Male, medicine.medical_specialty, 030204 cardiovascular system & hematology, Lower risk, law.invention, COVID-19, Disease severity, Hydroxychloroquine, Inflammation, Mortality, Aged, Aged, 80 and over, Female, Hospital Mortality, Humans, Italy, Middle Aged, Retrospective Studies, Treatment Outcome, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Retrospective Studie, law, Internal medicine, 80 and over, Internal Medicine, medicine, 030212 general & internal medicine, Risk factor, business.industry, Mortality rate, Retrospective cohort study, COVID-19 Drug Treatment, Propensity score matching, Commentary, Observational study, business, Human, medicine.drug
Abstract

Background Hydroxychloroquine (HCQ) was proposed as potential treatment for COVID-19. Objective We set-up a multicenter Italian collaboration to investigate the relationship between HCQ therapy and COVID-19 in-hospital mortality. Methods In a retrospective observational study, 3,451 unselected patients hospitalized in 33 clinical centers in Italy, from February 19, 2020 to May 23, 2020, with laboratory-confirmed SARS-CoV-2 infection, were analyzed. The primary end-point in a time-to event analysis was in-hospital death, comparing patients who received HCQ with patients who did not. We used multivariable Cox proportional-hazards regression models with inverse probability for treatment weighting by propensity scores, with the addition of subgroup analyses. Results Out of 3,451 COVID-19 patients, 76.3% received HCQ. Death rates (per 1,000 person-days) for patients receiving or not HCQ were 8.9 and 15.7, respectively. After adjustment for propensity scores, we found 30% lower risk of death in patients receiving HCQ (HR=0.70; 95%CI: 0.59 to 0.84; E-value=1.67). Secondary analyses yielded similar results. The inverse association of HCQ with inpatient mortality was particularly evident in patients having elevated C-reactive protein at entry. Conclusions HCQ use was associated with a 30% lower risk of death in COVID-19 hospitalized patients. Within the limits of an observational study and awaiting results from randomized controlled trials, these data do not discourage the use of HCQ in inpatients with COVID-19.

Published
2020

27. Missed linkage to care for patients who screened positive for Hepatitis C in a tertiary care centre: Results of the Telepass project

Author

Annalisa Tortora, Caterina Fanali, Massimo Siciliano, Vincenzina Mora, Francesca Romana Ponziani, Antonio Giulio de Belvis, Fulvio Balducci, Alisha Morsella, Maria Elena D'Alfonso, Maurizio Pompili, Francesco Santopaolo, G Vetrugno, Roberto Cauda, Andrea Cambieri, Antonio Gasbarrini, R. Bellantone, and Maurizio Sanguinetti

Subjects
Male, medicine.medical_specialty, Hepatitis C virus, Settore MED/12 - GASTROENTEROLOGIA, Hepacivirus, medicine.disease_cause, World Health Organization, Tertiary care, Antiviral Agents, Tertiary Care Centers, 03 medical and health sciences, 0302 clinical medicine, case finding, Virology, Internal medicine, Health care, Epidemiology, medicine, Retrospective analysis, Humans, 030212 general & internal medicine, Prospective Studies, Chronic, Telepass, DAA, linkage to care, Retrospective Studies, Hepatology, Recall, business.industry, Settore MED/09 - MEDICINA INTERNA, virus diseases, Diagnostic test, Hepatitis C, Hepatitis C, Chronic, medicine.disease, Infectious Diseases, HCV, 030211 gastroenterology & hepatology, Female, business, Delivery of Health Care
Abstract

Italy is one of the countries on track with the WHO's agenda to eliminate hepatitis C virus (HCV) by 2030. Healthcare facilities play a crucial role in seeking patients who are infected but have not yet been treated. We assessed the effectiveness of a recall strategy, named 'Telepass' project, for patients exposed to HCV infection who have not yet been linked to care in a large tertiary care centre. The 'Telepass' project was structured in two phases: (a) a retrospective analysis first identified all anti-HCV-positive subjects among patients who underwent pre-operative assessment in the facility in the course of one year; (b) a following prospective phase, aimed to recall patients in need either of further diagnostic tests (ie HCV-RNA) or treatment. A total of 12246 records of patients tested for HCV antibodies were reviewed. The overall prevalence of anti-HCV-positive subjects was 1.83% (224/12246) with a male/female ratio of 2.07. Out of the 224 anti-HCV-positive patients, 123 (54.91%) did not have documented HCV-RNA tests and were therefore selected for recall. Of these, 123 were reachable and 26 (21.13%) were successfully linked to care. Ten patients (38.46%) tested HCV-RNA positive and initiated treatment with direct-acting antivirals (DAAs). The Telepass study highlights that a recall strategy starting from internal hospital databases can help identify patients with chronic HCV infection who have not yet been linked to care, and provides an epidemiological insight into the prevalence of HCV infection in Italy in the late DAAs era.

Published
2020

28. A call to research: the relationship between SARS-2-CoV, ACE 2 and antihypertensives

Author

Antonio Cassone, Donatella Gucciardo, and Roberto Cauda

Subjects
2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Pneumonia, Viral, Angiotensin-Converting Enzyme Inhibitors, Blood Pressure, Peptidyl-Dipeptidase A, Microbiology, Mice, Viral genetics, Pandemic, Medicine, Animals, Humans, Viral, Lung, Pandemics, Antihypertensive Agents, business.industry, Public Health, Environmental and Occupational Health, COVID-19, Pneumonia, General Medicine, SARS Virus, medicine.disease, Virology, Spike Glycoprotein, Coronavirus, Infectious Diseases, Severe acute respiratory syndrome-related coronavirus, Angiotensin-converting enzyme 2, Spike Glycoprotein, Coronavirus, Parasitology, Angiotensin-Converting Enzyme 2, business, Coronavirus Infections, Protein Binding, Article Commentary
Published
2020
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29. Sarilumab use in severe SARS-CoV-2 pneumonia

Author

Gennaro De Pascale, Amerigo Iaconelli, Gian Ludovico Rapaccini, Michela Sali, L. Gigante, Antonio Gasbarrini, Lucrezia Verardi, Lorenzo Zileri Del Verme, Angelo Calabrese, Federico Biscetti, Massimo Fantoni, Alberto Tosoni, Silvia Laura Bosello, Gerlando Natalello, Matteo Garcovich, Stefano Alivernini, Barbara Tolusso, Luca Richeldi, Marco Maria Lizzio, Anna Laura Fedele, Maurizio Gabrielli, Roberto Bernabei, Angelo Santoliquido, Roberto Cauda, Maurizio Sanguinetti, Elisa Gremese, Francesco Landi, Raffaele Landolfi, Maurizio Pompili, Dario Bruno, Giovanni Gambassi, Massimo Montalto, Francesco Franceschi, Luca Petricca, Eleonora Taddei, Francesco Lombardi, Enrica Tamburrini, Massimo Antonelli, Antonella Cingolani, Simone Perniola, and Rita Murri

Subjects
medicine.medical_specialty, medicine.medical_treatment, Settore MED/17 - MALATTIE INFETTIVE, 01 natural sciences, Article, law.invention, Pulmonary function testing, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Informed consent, law, Oxygen therapy, medicine, 030212 general & internal medicine, 0101 mathematics, Inflammation, lcsh:R5-920, Severe sars-cov-2 pneumonia, Respiratory distress, business.industry, Mortality rate, 010102 general mathematics, Sarilumab, General Medicine, medicine.disease, Intensive care unit, respiratory tract diseases, Pneumonia, Anesthesia, Emergency medicine, Observational study, lcsh:Medicine (General), business
Abstract

Importance Interleukin-6 signal blockade has shown preliminary beneficial effects in treating aberrant host inflammatory response against SARS-CoV-2 leading to severe respiratory distress. Objective to describe the effect of off-label intravenous use of Sarilumab in patients with severe SARS-CoV-2-related pneumonia. Design Observational clinical cohort study. Setting Fondazione Policlinico Universitario A. Gemelli IRCCS as Italian Covid reference center. Participants Patients with laboratory-confirmed SARS-CoV-2 infection and respiratory distress with PaO2/FiO2 ratio Main outcomes and measures We describe the clinical outcomes of 53 patients with SARS-CoV-2 severe pneumonia treated with intravenous Sarilumab in terms of pulmonary function improvement or Intensive Care Unit (ICU) admission rate in medical wards setting and of live discharge rate in ICU treated patients as well as in terms of safety. Each patient received Sarilumab 400 mg administered intravenously on day 1, with eventual additional infusion based on clinical judgement, and was followed for at least 14 days, unless previously discharged or dead. No gluco-corticosteroids were used at baseline. Results Of the 53 SARS-CoV-2pos patients receiving Sarilumab, 39 (73.6%) were treated in medical wards (66.7% with a single infusion) while 14 (26.4%) in ICU (92.6% with a second infusion). The median PaO2/FiO2 of patients in the Medical Ward was 146(IQR:120-212) while the median PaO2/FiO2 of patients in ICU was 112(IQR:100-141.5), respectively. Within the medical wards, 7(17.9%) required ICU admission, 4 of whom were re-admitted to the ward within 5-8 days. At 19 days median follow-up, 89.7% of medical inpatients significantly improved (46.1% after 24 hours, 61.5% after 3 days), 70.6% were discharged from the hospital and 85.7% no longer needed oxygen therapy. Within patients receiving Sarilumab in ICU, 64.2% were discharged from ICU to the ward and 35.8% were still alive at the last follow-up. Overall mortality rate was 5.7% after Sarilumab administration: 1(2.5%) patient died in the Medical Ward whilst 2(14.2%) patients died in ICU, respectively. Conclusions and relevance IL-6R inhibition appears to be a potential treatment strategy for severe SARS-CoV-2 pneumonia and intravenous Sarilumab seems a promising treatment approach showing, in the short term, an important clinical benefit and good safety. Key points Question SARS-CoV-2 infection remains a disease with many unknown aspects for which there are no therapies with proven efficacy. To date, it is recognized that COVID-19 disease may lead to the development of a cytokine storm for which drugs as IL-6R inhibitors may have beneficial effect. Findings In this observational clinical study, we reported the efficacy and safety of intravenous Sarilumab use in SARS-CoV-2 severe pneumonia with a global resolution rate of 83.0% (89.7% in medical wards and 64.3% in ICU) and an overall mortality rate of 5.7%. Meaning IL-6R-inhibition is an effective approach for severe SARS-CoV-2 pneumonia and intravenous Sarilumab is a promising treatment approach leading to an important clinical benefit and good safety in the short term.

Published
2020

30. Challenges in COVID-19: is pulmonary thromboembolism related to overall severity?

Author

Francesco Landi, Luigi Larosa, Massimo Fantoni, Roberto Bernabei, Giuseppe Maria Corbo, Luca Richeldi, Enrica Intini, Andrea Bellieni, Eleonora Taddei, Rita Murri, Fabiana Baldi, and Roberto Cauda

Subjects
musculoskeletal diseases, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), 030106 microbiology, Pneumonia, Viral, MEDLINE, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, Betacoronavirus, 0302 clinical medicine, Risk Factors, Internal medicine, Pandemic, Medicine, Humans, 030212 general & internal medicine, Viral, Pandemics, Retrospective Studies, General Immunology and Microbiology, biology, business.industry, SARS-CoV-2, Disease progression, COVID-19, Retrospective cohort study, General Medicine, Pneumonia, medicine.disease, biology.organism_classification, Pulmonary embolism, Infectious Diseases, Disease Progression, business, Coronavirus Infections, Pulmonary Embolism
Abstract

To the Editor,In this journal Hou et al. recently reported their experience on clinical aggravation in COVID-19 patients [1]. Patients with disease progression were more likely to have various comp...

Published
2020

31. Knowing more about chloroquine/hydroxycloroquine in COVID-19 patients

Author

Licia Iacoviello, Antonio Cassone, and Roberto Cauda

Subjects
Microbiology (medical), 2019-20 coronavirus outbreak, hydroxychloroquine, Coronavirus disease 2019 (COVID-19), Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Anti-Inflammatory Agents, immunomodulation, Microbiology, Antiviral Agents, law.invention, Randomized controlled trial, law, Chloroquine, anti-inflammatory, antiviral, COVID-19, HCQ dosage, observational studies, randomized controlled trials, SARS-CoV-2, Humans, Hydroxychloroquine, Immunomodulation, Randomized Controlled Trials as Topic, Medicine, business.industry, Virology, Observational study, business, medicine.drug
Published
2020

32. RAAS inhibitors are not associated with mortality in COVID-19 patients: Findings from an observational multicenter study in Italy and a meta-analysis of 19 studies

Author

Francesca Santilli, Marianna Meschiari, Gabriella Guarnieri, Francesco Petri, Anna Sabena, Gloria Maccagni, Giovanni Larizza, Massimo Mapelli, Maria Mazzitelli, Gian Battista Danzi, Katleen de Gaetano Donati, Annalisa Crisetti, Jovana Milic, Raffaele Pesavento, Biagio Pinchera, Riccardo Maragna, Carlo Andrea Pivato, Lorenzo Menicanti, Francesco Maria Fusco, Luca Aiello, Sandro Mancarella, Carlo Sanrocco, Alessandra Vergori, Greta Barbieri, Filippo Aucella, Silvia Marongiu, Giulio Maresca, Marianna Rossi, Andrea Antinori, Venerino Poletti, Francesco Cacciatore, Giacomo Castiglione, Enrico Maria Trecarichi, Lucia Caiano, Francesca Crosta, Roberto Vettor, Francesco Menichetti, Maria Musso, Francesco Salinaro, Marco Olivieri, Stefano Perlini, Claudia Colomba, Crizia Colombo, Ottavia Cozzi, Stefano Maitan, Marialaura Bonaccio, Ilaria My, Alexandra Virano, Paola Simeone, Marco Vinceti, Antonella Cingolani, Gianpiero D'Offizi, Damiano D'Ardes, Claudia Marotta, M. B. Lucia, Carlo Signorelli, Lorenzo Marra, Giuseppe Patti, Raffaele De Caterina, Armando Leone, Veronica Lio, Beatrice Molena, Giustino Parruti, Giulio G. Stefanini, Licia Iacoviello, Laura Vocciante, Franco Mastroianni, Raffaella Sgariglia, Cristina Mussini, Francesco Cipollone, Marco Rossato, Lorenzo Blandi, Emanuela Pasi, Samir Al Moghazi, Andrea Vianello, Filippo Minutolo, Ivan Gentile, Giovanni Guaraldi, Rosa Manuele, Pasquale Abete, Arturo Ciccullo, Antonella Palimodde, Giancarlo Scoppettuolo, Walter Ageno, Marco G. Mennuni, Roberta Mussinelli, Vincenzo Sangiovanni, Roberto Cauda, Laura Scorzolini, Paolo Bonfanti, Alessandro Gialluisi, Stefania Cianfrone, Piergiuseppe Agostoni, Antonio Cascio, Simona Costanzo, Augusto Di Castelnuovo, Nausicaa Berselli, Rosa Arboretti, Emauele Graziani, Martina Barchitta, Anna Odone, Francesco Di Gennaro, Alessandro Mengozzi, Alessandro Bartoloni, Giuseppe Di Tano, Laura Carrozzi, Ferruccio Madaro, Rossella Marcucci, Claudia Ravaglia, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Cauda, Roberto, Gialluisi, Alessandro, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, Mussinelli, Roberta, My, Ilaria, Parruti, Giustino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G., Vergori, Alessandra, Abete, Pasquale, Ageno, Walter, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Arboretti, Rosa, Aucella, Filippo, Barbieri, Greta, Barchitta, Martina, Bartoloni, Alessandro, Bonfanti, Paolo, Cacciatore, Francesco, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Castiglione, Giacomo, Cianfrone, Stefania, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Cozzi, Ottavia, Crisetti, Annalisa, Crosta, Francesca, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Fusco, Francesco Maria, Gentile, Ivan, Graziani, Emauele, Guarnieri, Gabriella, Larizza, Giovanni, Leone, Armando, Lio, Veronica, Lucia, Mothanje Barbara, Maccagni, Gloria, Madaro, Ferruccio, Maitan, Stefano, Mancarella, Sandro, Manuele, Rosa, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marongiu, Silvia, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Meschiari, Marianna, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Palimodde, Antonella, Pasi, Emanuela, Pesavento, Raffaele, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A., Poletti, Venerino, Ravaglia, Claudia, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scoppettuolo, Giancarlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Trecarichi, Enrico Maria, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Virano, Alexandra, Vocciante, Laura, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo, A., Costanzo, S., Antinori, A., Berselli, N., Bl, I, L., Bonaccio, M., Cauda, R., Gialluisi, A., Guaraldi, G., Menicanti, L., Mennuni, M., Mussinelli, R., My, I., Parruti, G., Patti, G., Perlini, S., Santilli, F., Signorelli, C., Stefanini, G. G., Vergori, A., Abete, P., Ageno, W., Agostoni, P., Aiello, L., Al Moghazi, S., Arboretti, R., Aucella, F., Barbieri, G., Barchitta, M., Bartoloni, A., Bonfanti, P., Cacciatore, F., Caiano, L., Carrozzi, L., Cascio, A., Castiglione, G., Cianfrone, S., Ciccullo, A., Cingolani, A., Cipollone, F., Colomba, C., Colombo, C., Cozzi, O., Crisetti, A., Crosta, F., Danzi, G. B., D'Ardes, D., de Gaetano Donati, K., Di Gennaro, F., Di Tano, G., D'Offizi, G., Fusco, F. M., Gentile, I., Graziani, E., Guarnieri, G., Larizza, G., Leone, A., Lio, V., Lucia, M. B., Maccagni, G., Madaro, F., Maitan, S., Mancarella, S., Manuele, R., Mapelli, M., Maragna, R., Marcucci, R., Maresca, G., Marongiu, S., Marotta, C., Marra, L., Mastroianni, F., Mazzitelli, M., Mengozzi, A., Menichetti, F., Meschiari, M., Milic, J., Minutolo, F., Molena, B., Mussini, C., Musso, M., Odone, A., Olivieri, M., Palimodde, A., Pasi, E., Pesavento, R., Petri, F., Pinchera, B., Pivato, C. A., Poletti, V., Ravaglia, C., Rossato, M., Rossi, M., Sabena, A., Salinaro, F., Sangiovanni, V., Sanrocco, C., Scoppettuolo, G., Scorzolini, L., Sgariglia, R., Simeone, P. G., Trecarichi, E. M., Vettor, R., Vianello, A., Vinceti, M., Virano, A., Vocciante, L., De Caterina, R., Iacoviello, L., Blandi, L., Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Cauda, R, Gialluisi, A, Guaraldi, G, Menicanti, L, Mennuni, M, Mussinelli, R, My, I, Parruti, G, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Abete, P, Ageno, W, Agostoni, P, Aiello, L, Al Moghazi, S, Arboretti, R, Aucella, F, Barbieri, G, Barchitta, M, Bartoloni, A, Bonfanti, P, Cacciatore, F, Caiano, L, Carrozzi, L, Cascio, A, Castiglione, G, Cianfrone, S, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Cozzi, O, Crisetti, A, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Fusco, F, Gentile, I, Graziani, E, Guarnieri, G, Larizza, G, Leone, A, Lio, V, Lucia, M, Maccagni, G, Madaro, F, Maitan, S, Mancarella, S, Manuele, R, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marongiu, S, Marotta, C, Marra, L, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Milic, J, Minutolo, F, Molena, B, Mussini, C, Musso, M, Odone, A, Olivieri, M, Palimodde, A, Pasi, E, Pesavento, R, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scoppettuolo, G, Scorzolini, L, Sgariglia, R, Simeone, P, Trecarichi, E, Vettor, R, Vianello, A, Vinceti, M, Virano, A, Vocciante, L, Iacoviello, L, and De Caterina, R

Subjects
0301 basic medicine, Male, Physiology, Middle Aged, Renin-Angiotensin System, Angiotensin-Converting Enzyme Inhibitors, 030204 cardiovascular system & hematology, ACE-I, ARB, COVID-19, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, mortality, sartans, Severity of Illness Index, Renin-Angiotensin System, 0302 clinical medicine, Risk Factors, 80 and over, Medicine, Hospital Mortality, Sartan, Aged, 80 and over, Incidence (epidemiology), Incidence, Hazard ratio, Angiotensin Receptor Antagonist, Middle Aged, Hospitalization, Antihypertensive Agent, Italy, Meta-analysis, Hypertension, Sartans, Molecular Medicine, Female, Risk assessment, Human, medicine.medical_specialty, Angiotensin converting enzyme inhibitors, Angiotensin receptor blockers, Mortality, Coronavirus disease 2019 (COVID-19), Risk Assessment, Article, COVID−19, 03 medical and health sciences, Angiotensin Receptor Antagonists, Meta-Analysis as Topic, Internal medicine, Severity of illness, Humans, Angiotensin receptor blocker, Antihypertensive Agents, Aged, Pharmacology, business.industry, Risk Factor, Angiotensin-Converting Enzyme Inhibitor, Confidence interval, 030104 developmental biology, COVID-19, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, mortality, sartans, Observational study, Angiotensin converting enzyme inhibitor, business
Abstract

Objective The hypothesis that been set forward that use of Renin Angiotensin Aldosterone System (RAAS) inhibitors is associated with COVID−19 severity. We set-up a multicenter Italian collaboration (CORIST Project, ClinicalTrials.gov ID: NCT04318418 ) to retrospectively investigate the relationship between RAAS inhibitors and COVID−19 in-hospital mortality. We also carried out an updated meta-analysis on the relevant studies. Methods We analyzed 4069 unselected patients with laboratory-confirmed SARS-CoV-2 infection and hospitalized in 34 clinical centers in Italy from February 19, 2020 to May 23, 2020. The primary end-point in a time-to event analysis was in-hospital death, comparing patients who received angiotensin-converting–enzyme inhibitors (ACE I) or angiotensin-receptor blockers (ARB) with patients who did not. Articles for the meta-analysis were retrieved until July 13th, 2020 by searching in web-based libraries, and data were combined using the general variance-based method. Results Out of 4069 COVID−19 patients, 13.5% and 13.3% received ACE-I or ARB, respectively. Use of neither ACE-I nor ARB was associated with mortality (multivariable hazard ratio (HR) adjusted also for COVID−19 treatments: 0.96, 95% confidence interval 0.77–1.20 and HR = 0.89, 0.67–1.19 for ACE-I and ARB, respectively). Findings were similar restricting the analysis to hypertensive (N = 2057) patients (HR = 1.00, 0.78–1.26 and HR = 0.88, 0.65–1.20) or when ACE-I or ARB were considered as a single group. Results from the meta-analysis (19 studies, 29,057 COVID−19 adult patients, 9700 with hypertension) confirmed the absence of association. Conclusions In this observational study and meta-analysis of the literature, ACE-I or ARB use was not associated with severity or in-hospital mortality in COVID−19 patients.

Published
2020

33. Neutrophil-to-lymphocyte ratio and clinical outcome in COVID-19: a report from the Italian front line

Author

Massimo Montalto, Alberto Borghetti, Lorenzo Zileri Dal Verme, Simona Di Giambenedetto, Roberto Cauda, Alberto Tosoni, Francesca Lombardi, Arturo Ciccullo, Federico Biscetti, and Matteo Garcovich

Subjects
0301 basic medicine, Microbiology (medical), Male, medicine.medical_specialty, Younger age, Coronavirus disease 2019 (COVID-19), Neutrophils, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), 030106 microbiology, Pneumonia, Viral, Settore MED/17 - MALATTIE INFETTIVE, Article, 03 medical and health sciences, Betacoronavirus, Leukocyte Count, 0302 clinical medicine, Internal medicine, Medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Lymphocytes, Viral, Neutrophil to lymphocyte ratio, Pandemics, Aged, Retrospective Studies, business.industry, SARS-CoV-2, fungi, COVID-19, Front line, Retrospective cohort study, General Medicine, Pneumonia, Middle Aged, Prognosis, Infectious Diseases, Treatment Outcome, Italy, Cohort, Female, business, Coronavirus Infections
Abstract

• Clinicians are looking for a reliable prognostic marker for patients with COVID-19. • In our cohort, clinical improvement was predicted by younger age and a NLR below 3. • Transfer to ICU was instead predicted by a NLR over 4 (p=0.046). • NLR is a fast, widely available and relatively inexpensive assessment. • NLR may be a useful tool in the early screening of patients with COVID-19.

Published
2020

34. Ethical criteria for the admission and management of patients in the ICU under conditions of limited medical resources : a shared international proposal in view of the COVID-19 pandemic

Author

Vittoradolfo Tambone, Donald Boudreau, Massimo Ciccozzi, Karen Sanders, Laura Leondina Campanozzi, Jane Wathuta, Luciano Violante, Roberto Cauda, Carlo Petrini, Antonio Abbate, Rossana Alloni, Josepmaria Argemi, Josep Argemí Renom, Anna De Benedictis, France Galerneau, Emilio García-Sánchez, Giampaolo Ghilardi, Janet Palmer Hafler, Magdalena Linden, Alfredo Marcos, Andrea Onetti Muda, Marco Pandolfi, Thierry Pelaccia, Mario Picozzi, Ruben Oscar Revello, Giovanna Ricci, Robert Rohrbaugh, Patrizio Rossi, Ascanio Sirignano, Antonio Gioacchino Spagnolo, Trevor Stammers, Lourdes Velázquez, Evandro Agazzi, Mark Mercurio, Producción Científica UCH 2020, and UCH. Departamento de Ciencias Políticas, Ética y Sociología

Subjects
2019-20 coronavirus outbreak, Opinion, Internationality, Coronavirus disease 2019 (COVID-19), Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Intensive Care Unit, MEDLINE, COVID-19 (Disease) - Hospitals - Moral and ethical aspects, Cuidados intensivos - Aspectos éticos, Settore MED/17 - MALATTIE INFETTIVE, law.invention, disaster medicine, law, Pandemic, common good, medicine, Humans, COVID-19 - Hospitales - Aspectos éticos, Common good, COVID-19, Disaster medicine, Ethical triage criteria, Health Care Rationing, business.industry, lcsh:Public aspects of medicine, ethical triage criteria, Critical care medicine - Moral and ethical aspects, Public Health, Environmental and Occupational Health, lcsh:RA1-1270, Settore MED/43 - MEDICINA LEGALE, medicine.disease, Intensive care unit, COVID-19 (Disease) - Patients - Moral and ethical aspects, Hospitalization, Intensive Care Units, Medical emergency, Public Health, Hospitales - Admisión - Aspectos éticos, Triage, COVID-19 - Pacientes - Aspectos éticos, business, Hospitals - Admission - Moral and ethical aspects
Abstract

Este artículo se encuentra disponible en la siguiente URL: https://www.frontiersin.org/articles/10.3389/fpubh.2020.00284/full En este artículo también participan: Luciano Violante, Roberto Cauda, Carlo Petrini, Antonio Abbate, Rossana Alloni, Josepmaria Argemi, Josep Argemí Renom, Anna De Benedictis, France Galerneau, Giampaolo Ghilardi, Janet Palmer Hafler, Magdalena Linden, Alfredo Marcos, Andrea Onetti Muda, Marco Pandolfi, Thierry Pelaccia, Mario Picozzi, Ruben Oscar Revello, Giovanna Ricci, Robert Rohrbaugh, Patrizio Rossi, Ascanio Sirignano, Antonio Gioacchino Spagnolo, Trevor Stammers, Lourdes Velázquez, Evandro Agazzi y Mark Mercurio.

Published
2020

35. COVID-19 and intestinal inflammation: Role of fecal calprotectin

Author

Veronica Ojetti, Angela Saviano, Marcello Covino, Nicola Acampora, Eliana Troiani, Francesco Franceschi, Valeria Abbate, Giovanni Addolorato, Fabiana Agostini, Maria Elena Ainora, Karim Akacha, Elena Amato, Francesca Andreani, Gloria Andriollo, Maria Giuseppina Annetta, Brigida Eleonora Annicchiarico, Mariangela Antonelli, Gabriele Antonucci, Gian Marco Anzellotti, Alessandro Armuzzi, Fabiana Baldi, Ilaria Barattucci, Christian Barillaro, Fabiana Barone, Rocco Domenico Alfonso Bellantone, Andrea Bellieni, Giuseppe Bello, Andrea Benicchi, Francesca Benvenuto, Ludovica Berardini, Filippo Berloco, Roberto Bernabei, Antonio Bianchi, Daniele Guerino Biasucci, Luigi Marzio Biasucci, Stefano Bibbò, Alessandra Bini, Alessandra Bisanti, Federico Biscetti, Maria Grazia Bocci, Nicola Bonadia, Filippo Bongiovanni, Alberto Borghetti, Giulia Bosco, Silvia Bosello, Vincenzo Bove, Giulia Bramato, Vincenzo Brandi, Teresa Bruni, Carmine Bruno, Dario Bruno, Maria Chiara Bungaro, Alessandro Buonomo, Livia Burzo, Angelo Calabrese, Maria Rosaria Calvello, Andrea Cambieri, Chiara Cambise, Giulia Cammà, Marcello Candelli, Gennaro Canistro, Antonello Cantanale, Gennaro Capalbo, Lorenzo Capaldi, Emanuele Capone, Esmeralda Capristo, Luigi Carbone, Silvia Cardone, Simone Carelli, Angelo Carfì, Annamaria Carnicelli, Cristiano Caruso, Francesco Antonio Casciaro, Lucio Catalano, Roberto Cauda, Andrea Leonardo Cecchini, Lucia Cerrito, Melania Cesarano, Annalisa Chiarito, Rossella Cianci, Sara Cicchinelli, Arturo Ciccullo, Marta Cicetti, Francesca Ciciarello, Antonella Cingolani, Maria Camilla Cipriani, Maria Ludovica Consalvo, Gaetano Coppola, Giuseppe Maria Corbo, Andrea Corsello, Federico Costante, Matteo Costanzi, Davide Crupi, Salvatore Lucio Cutuli, Stefano D'Addio, Alessia D'Alessandro, Maria ElenaEmanuela D'AlfonsoD'Angelo, Francesca D'Aversa, Fernando Damiano, Gian Maria De Berardinis, Tommaso De Cunzo, Donati Katleen De Gaetano, Giulio De Luca, Giuseppe De Matteis, Gennaro De Pascale, Paolo De Santis, Martina De Siena, Francesco De Vito, Valeria Del Gatto, Paola Del Giacomo, Fabio Del Zompo, Antonio Maria Dell'Anna, Davide Della Polla, Luca Di Gialleonardo, Simona Di Giambenedetto, Roberta Di Luca, Luca Di Maurizio, Mariangela Di Muro, Alex Dusina, Davide Eleuteri, Alessandra Esperide, Daniele Fachechi, Domenico Faliero, Cinzia Falsiroli, Massimo Fantoni, Annalaura Fedele, Daniela Feliciani, Cristina Ferrante, Giuliano Ferrone, Rossano Festa, Maria Chiara Fiore, Andrea Flex, Evelina Forte, Alessandra Francesconi, Laura Franza, Barbara Funaro, Mariella Fuorlo, Domenico Fusco, Maurizio Gabrielli, Eleonora Gaetani, Claudia Galletta, Antonella Gallo, Giovanni Gambassi, Matteo Garcovich, Antonio Gasbarrini, Irene Gasparrini, Silvia Gelli, Antonella Giampietro, Laura Gigante, Gabriele Giuliano, Giorgia Giuliano, Bianca Giupponi, Elisa Gremese, Domenico Luca Grieco, Manuel Guerrera, Valeria Guglielmi, Caterina Guidone, Antonio Gullì, Amerigo Iaconelli, Aurora Iafrati, Gianluca Ianiro, Angela Iaquinta, Michele Impagnatiello, Riccardo Inchingolo, Enrica Intini, Raffaele Iorio, Immacolata Maria Izzi, Tamara Jovanovic, Cristina Kadhim, Rosa La Macchia, Daniele Ignazio La Milia, Francesco Landi, Giovanni Landi, Rosario Landi, Raffaele Landolfi, Massimo Leo, Paolo Maria Leone, Laura Levantesi, Antonio Liguori, Rosa Liperoti, Marco Maria Lizzio, Maria Rita Lo Monaco, Pietro Locantore, Francesco Lombardi, Gianmarco Lombardi, Loris Lopetuso, Valentina Loria, Angela Raffaella Losito, Mothanje Barbara Patricia Lucia, Francesco Macagno, Noemi Macerola, Giampaolo Maggi, Giuseppe Maiuro, Francesco Mancarella, Francesca Mangiola, Alberto Manno, Debora Marchesini, Gian Marco Maresca, Giuseppe Marrone, Ilaria Martis, Anna Maria Martone, Emanuele Marzetti, Chiara Mattana, Maria Valeria Matteo, Riccardo Maviglia, Ada Mazzarella, Carmen Memoli, Luca Miele, Alessio Migneco, Irene Mignini, Alessandro Milani, Domenico Milardi, Massimo Montalto, Giuliano Montemurro, Flavia Monti, Luca Montini, Tony Christian Morena, Vincenzina Morra, Chiara Morretta, Davide Moschese, Celeste Ambra Murace, Martina Murdolo, Rita Murri, Marco Napoli, Elisabetta Nardella, Gerlando Natalello, Daniele Natalini, Simone Maria Navarra, Antonio Nesci, Alberto Nicoletti, Rocco Nicoletti, Tommaso Filippo Nicoletti, Rebecca Nicolò, Nicola Nicolotti, Enrico Celestino Nista, Eugenia Nuzzo, Marco Oggiano, Francesco Cosimo Pagano, Gianfranco Paiano, Cristina Pais, Federico Pallavicini, Andrea Palombo, Federico Paolillo, Alfredo Papa, Domenico Papanice, Luigi Giovanni Papparella, Mattia Paratore, Giuseppe Parrinello, Giuliana Pasciuto, Pierpaolo Pasculli, Giovanni Pecorini, Simone Perniola, Erika Pero, Luca Petricca, Martina Petrucci, Chiara Picarelli, Andrea Piccioni, Annalisa Piccolo, Edoardo Piervincenzi, Giulia Pignataro, Raffaele Pignataro, Gabriele Pintaudi, Luca Pisapia, Marco Pizzoferrato, Fabrizio Pizzolante, Roberto Pola, Caterina Policola, Maurizio Pompili, Flavia Pontecorvi, Valerio Pontecorvi, Francesca Ponziani, Valentina Popolla, Enrica Porceddu, Angelo Porfidia, Lucia Maria Porro, Annalisa Potenza, Francesca Pozzana, Giuseppe Privitera, Daniela Pugliese, Gabriele Pulcini, Simona Racco, Francesca Raffaelli, Vittoria Ramunno, Gian Ludovico Rapaccini, Luca Richeldi, Emanuele Rinninella, Sara Rocchi, Bruno Romanò, Stefano Romano, Federico Rosa, Laura Rossi, Raimondo Rossi, Enrica Rossini, Elisabetta Rota, Fabiana Rovedi, Carlotta Rubino, Gabriele Rumi, Andrea Russo, Luca Sabia, Andrea Salerno, Sara Salini, Lucia Salvatore, Dehara Samori, Claudio Sandroni, Maurizio Sanguinetti, Luca Santarelli, Paolo Santini, Danilo Santolamazza, Angelo Santoliquido, Francesco Santopaolo, Michele Cosimo Santoro, Francesco Sardeo, Caterina Sarnari, Luisa Saviano, Franco Scaldaferri, Roberta Scarascia, Tommaso Schepis, Francesca Schiavello, Giancarlo Scoppettuolo, Davide Sedda, Flaminio Sessa, Luisa Sestito, Carlo Settanni, Matteo Siciliano, Valentina Siciliano, Rossella Sicuranza, Benedetta Simeoni, Jacopo Simonetti, Andrea Smargiassi, Paolo Maurizio Soave, Chiara Sonnino, Domenico Staiti, Claudia Stella, Leonardo Stella, Eleonora Stival, Eleonora Taddei, Rossella Talerico, Elio Tamburello, Enrica Tamburrini, Eloisa Sofia Tanzarella, Elena Tarascio, Claudia Tarli, Alessandra Tersali, Pietro Tilli, Jacopo Timpano, Enrico Torelli, Flavia Torrini, Matteo Tosato, Alberto Tosoni, Luca Tricoli, Marcello Tritto, Mario Tumbarello, Anita Maria Tummolo, Maria Sole Vallecoccia, Federico Valletta, Francesco Varone, Francesco Vassalli, Giulio Ventura, Lucrezia Verardi, Lorenzo Vetrone, Giuseppe Vetrugno, Elena Visconti, Felicia Visconti, Andrea Viviani, Raffaella Zaccaria, Carmelina Zaccone, Lorenzo Zelano, Lorenzo Zileri Dal Verme, and Giuseppe Zuccalà

Subjects
Adult, Male, medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Settore MED/12 - GASTROENTEROLOGIA, Pneumonia, Viral, Severity of Illness Index, Gastroenterology, Betacoronavirus, Feces, Intestinal mucosa, Intestinal inflammation, Internal medicine, Settore MED/41 - ANESTESIOLOGIA, medicine, Humans, Viral, Intestinal Mucosa, Letter to the Editor, Pandemics, Leukocyte L1 Antigen Complex, Hepatology, SARS-CoV-2, business.industry, Settore MED/09 - MEDICINA INTERNA, COVID-19, Pneumonia, Middle Aged, fecal calprotectin, Case-Control Studies, Female, Calprotectin, Coronavirus Infections, business, Biomarkers
Published
2020

36. Evolution of cellular HIV DNA levels in virologically suppressed patients switching to dolutegravir/lamivudine versus maintaining a triple regimen: a prospective, longitudinal, matched, controlled study

Author

Simone Belmonti, Enrica Tamburrini, Simona Marchetti, Francesca Lombardi, Massimiliano Fabbiani, Alberto Borghetti, Simona Di Giambenedetto, and Roberto Cauda

Subjects
Microbiology (medical), medicine.medical_specialty, Anti-HIV Agents, Pyridones, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, Settore MED/17 - MALATTIE INFETTIVE, Gastroenterology, Piperazines, chemistry.chemical_compound, Maintenance therapy, Internal medicine, Oxazines, medicine, Humans, Pharmacology (medical), Prospective Studies, Cd4 cell count, Pharmacology, business.industry, Lamivudine, DNA, Viral Load, Regimen, Infectious Diseases, chemistry, Homogeneous, Dolutegravir, hiv dna, HIV-1, HIV DNA level, business, cellular, Heterocyclic Compounds, 3-Ring, CD8, medicine.drug
Abstract

Objectives To assess the impact of switching to dolutegravir plus lamivudine maintenance therapy on the HIV cellular reservoir size. Patients and methods This was a prospective, longitudinal, matched, controlled study. We enrolled virologically suppressed patients on stable three-drug ART who switched at baseline (BL) to dolutegravir/lamivudine (DT group) or maintained triple therapy (TT group); subjects in the TT group were matched 1:1 with those in the DT group according to age, gender, years since HIV diagnosis, years on ART and anchor drug. Total blood-associated HIV DNA levels were assessed by droplet digital PCR at BL and after 48 weeks (T48). Results were expressed as log10 HIV DNA copies/106 leucocytes. Results We enrolled 40 patients in the DT group and 40 in the TT group; the two groups were homogeneous for all main characteristics except nadir CD4 cell count. At BL, HIV DNA levels were comparable between the DT and TT groups: 2.27 (IQR 1.97–2.47) and 2.26 (IQR 2.05–2.61) log10 HIV DNA copies/106 leucocytes, respectively. Change in HIV DNA load from BL to T48 was −0.105 (IQR −0.384 to 0.121, P = 0.041) in the DT group and −0.132 (IQR −0.362 to 0.046, P = 0.005) in the TT group, with a comparable decline observed between the two groups (P = 0.821). A higher HIV DNA decline was associated with higher BL CD4/CD8 ratio. Conclusions Maintenance therapy with dolutegravir/lamivudine had the same impact as the triple regimen on HIV DNA levels after 48 weeks of treatment. These data seem to support the effectiveness of a dolutegravir/lamivudine dual regimen in controlling the magnitude of the cellular reservoir (www.clinicaltrials.gov, number NCT02836782).

Published
2019

37. Effect of combination therapy containing a high-dose carbapenem on mortality in patients with carbapenem-resistant Klebsiella pneumoniae bloodstream infection

Author

Carolina Saffioti, Maddalena Giannella, Pierluigi Viale, Silvia Corcione, Claudio Viscoli, Simone Ambretti, Gian Maria Rossolini, Mario Tumbarello, Michele Bartoletti, Teresa Spanu, Angela Raffaella Losito, Alessandro Bartoloni, Russell E. Lewis, Anna Marchese, Sara K. Tedeschi, Matteo Bassetti, Enrico Maria Trecarichi, Valerio Del Bono, Daniele Roberto Giacobbe, Francesca Raffaelli, Roberto Cauda, Francesco Giuseppe De Rosa, Giannella, Maddalena, Trecarichi, Enrico Maria, Giacobbe, Daniele Roberto, De Rosa, Francesco Giuseppe, Bassetti, Matteo, Bartoloni, Alessandro, Bartoletti, Michele, Losito, Angela Raffaella, del Bono, Valerio, Corcione, Silvia, Tedeschi, Sara, Raffaelli, Francesca, Saffioti, Carolina, Spanu, Teresa, Rossolini, Gian Maria, Marchese, Anna, Ambretti, Simone, Cauda, Roberto, Viscoli, Claudio, Russel Edward Lewi, Viale, Pierluigi, and Tumbarello, Mario

Subjects
Male, 0301 basic medicine, Carbapenem, Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, Klebsiella pneumoniae, Tertiary Care Center, Bacteremia, Minocycline, Tigecycline, Carbapenem-resistant enterobacteriaceae, combination therapy, Tertiary Care Centers, Pharmacology (medical), Gentamicin, CR-KP, Bloodstream infection, carbapenem, biology, General Medicine, Middle Aged, Treatment Outcome, Combination therapy, Microbiology (medical), Infectious Diseases, Drug Therapy, Combination, Female, Human, medicine.drug, medicine.medical_specialty, 030106 microbiology, Infectious Disease, 03 medical and health sciences, Internal medicine, Drug Resistance, Bacterial, medicine, Humans, Propensity Score, Aged, Colistin, business.industry, bacterial infections and mycoses, biology.organism_classification, medicine.disease, Klebsiella Infections, Surgery, Carbapenem-Resistant Enterobacteriaceae, Carbapenems, Gentamicins, business, Klebsiella Infection
Abstract

Objectives: To evaluate the impact of high-dose (HD) carbapenem-based combination therapy on clinical outcome in patients with monomicrobial carbapenem-resistant Klebsiella pneumoniae (CR-KP) bloodstream-infection (BSI). Methods: Post hoc analysis of all adult patients with CR-KP BSI who were treated with a combination antibiotic regimen, collected over a six-year period in six large Italian teaching hospitals. To control for confounding effects of HD carbapenem combination on 14-day mortality, a multivariate Cox regression analysis was performed. Due to imbalances between patients, a propensity score for receiving HD carbapenem was added to the model. Results: 595 patients with CR-KP BSI were analysed, 77% of isolates showed a carbapenem MIC ≥16 mg/L, 428 (71.9%) received HD carbapenem-based combination therapy. Overall, 127 patients (21.3%) died within 14 days after BSI onset. Multivariate analysis showed the Charlson comorbidity index (HR 1.31, 95%CI 1.20–1.43, P < 0.001), septic shock at BSI onset (HR 3.14, 95%CI 2.19–4.50, P < 0.001), and colistin-resistant strain (HR 1.52, 95%CI 1.02–2.24, P = 0.03) were independently associated with 14-day mortality, whereas admission to surgical ward (HR 0.44, 95%CI 0.25–0.78, P = 0.005) and HD carbapenem use (HR 0.69, 95%CI 0.47–1.00, P = 0.05) were protective factors. When adjusted for the propensity score, HD carbapenem use showed a greater protective effect (HR 0.64, 95%CI 0.43–0.95, P = 0.03). Stratifying the model for carbapenem MIC, the benefit of HD carbapenem was also observed for strains with carbapenem MIC ≥16 mg/L. Conclusions: In patients receiving combination therapy for CR-KP BSI, the use of HD carbapenem seems to be associated with better outcome, even in the presence of high-level carbapenem resistance.

Published
2018

38. People Living with HIV in the COVID-19 Era: A Case Report

Author

F. Pallavicini, Enrica Tamburrini, Simona Di Giambenedetto, Damiano Farinacci, Elena Visconti, Immacolata Izzi, Alberto Borghetti, Roberto Cauda, and Arturo Ciccullo

Subjects
0301 basic medicine, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Side effect, business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Immunology, Pneumocystis jirovecii Pneumonia, Human immunodeficiency virus (HIV), HIV, Settore MED/17 - MALATTIE INFETTIVE, medicine.disease_cause, Virology, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Infectious Diseases, covid-19, medicine, 030212 general & internal medicine, business, COVID
Abstract

Little is known about the characteristics of SARS-CoV-2 infection in immunosuppressed people living with HIV. This report describes a case of a HIVinfected patient with Pneumocystis jirovecii pneumonia and CoVid-19 who died because of treatment's side effect. This case teaches us that fragile people may need different therapeutic strategies.

Published
2021

39. Generic antiretrovirals for the treatment of HIV: a novel challenge for Western countries?

Author

Gianpiero Carosi, Roberto Cauda, Dario Cattaneo, Giuliano Rizzardini, Adriano Lazzarin, and Massimo Andreoni

Subjects
0301 basic medicine, Therapeutic equivalency, Anti-HIV Agents, Cost-Benefit Analysis, Human immunodeficiency virus (HIV), Developing country, HIV Infections, Settore MED/17 - MALATTIE INFETTIVE, medicine.disease_cause, Generic, Drug Substitution, Drug Costs, Health Services Accessibility, Medication Adherence, 03 medical and health sciences, Cost Savings, Generics, medicine, Drugs, Generic, Humans, Pharmacology (medical), Developing Countries, Bioequivalence, Pharmacology, Cost–benefit analysis, HIV, Drugs, 030112 virology, Cost savings, Drug Combinations, Treatment Outcome, Therapeutic Equivalency, Risk analysis (engineering), Cd4 cell, Business, Clinical studies, Developed country
Abstract

The introduction of generic antiretroviral medications in developing countries has resulted in significant CD4 cell restoration, HIV viral decline, and a noteworthy reduction in the time to initiation of therapy. Projection models have also predicted significant cost saving associated with the extensive diffusion of generic antiretrovirals in developed countries. However, some uncertainties on generics have recently been raised. These concerns mainly relate to the adequacy of the study design for bioequivalence testing, the potential for uncontrolled switching from one generic to another, and the loss of adherence if patients switched from fixed-dose coformulations to single components in order to incorporate the new generic drugs. In the present review, we deal with current evidence and potential controversial issues regarding generic antiretrovirals and their underlying economic implications and provide some proposals on how to favor the widespread diffusion of generics in HIV medicine. This may be particularly relevant considering that the safe, systematic switch from patented to generic antiretrovirals could potentially guarantee access to therapies for HIV-infected patients worldwide and lead to money savings that would compensate the expenditure increase resulting from new, innovative HIV drugs. .

Published
2017

40. New classification for the treatment of pyogenic spondylodiscitis: validation study on a population of 250 patients with a follow-up of 2 years

Author

Enrico Pola, Massimo Fantoni, Roberto Cauda, V. M. Formica, V. Pambianco, G Autore, Debora Colangelo, Pola, Enrico, Autore, G., Formica, V. M., Pambianco, V., Colangelo, Debora, Cauda, Roberto, and Fantoni, Massimo

Subjects
medicine.medical_specialty, Discitis, Complications, Decompression, Population, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Healing rate, Back pain, Humans, Medicine, Orthopedics and Sports Medicine, 030212 general & internal medicine, education, Spondylodisciti, education.field_of_study, Suppuration, business.industry, Incidence (epidemiology), Standard treatment, Spondylodiscitis, Classification, Surgery, Settore MED/33 - MALATTIE APPARATO LOCOMOTORE, Radiography, Treatment Outcome, Radiological weapon, Orthopedic surgery, medicine.symptom, business, Complication, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

Purpose: Pyogenic spondylodiscitis (PS) is still burdened by a high rate of orthopedic and neurological complications. Despite the rising incidence, the choice of a proper orthopedic treatment is often delayed by the lack of clinical data. The aim of this study was to propose a clinical-radiological classification of pyogenic spondylodiscitis to define a standard treatment algorithm. Methods: Based on data from 250 patients treated from 2008 to 2015, a clinical-radiological classification of pyogenic spondylodiscitis was developed. According to primary classification criteria (bone destruction or segmental instability, epidural abscesses and neurological impairment), three main classes were identified. Subclasses were defined according to secondary criteria. PS without segmental instability or neurological impairment was treated conservatively. When significant bone loss or neurological impairment occurred, surgical stabilization and/or decompression were performed. All patients underwent clinical and radiological 2-year follow-up. Results: Type A PS occurred in 84 patients, while 46 cases were classified as type B and 120 as type C. Average time of hospitalization was 51.94 days and overall healing rate was 92.80%. 140 patients (56.00%) were treated conservatively with average time of immobilization of 218.17 ± 9.89 days. Both VAS and SF-12 scores improved across time points in all classes. Residual chronic back pain occurred in 27 patients (10.80%). Overall observed mortality was 4.80%. Conclusions: Standardized treatment of PS is highly recommended to ensure patients a good quality of life. The proposed scheme includes all available orthopedic treatments and helps spine surgeons to significantly reduce complications and costs and to avoid overtreatment.

Published
2017

41. Impact of Antiretroviral Therapy on the Risk of Recurrence in HIV-1 Infected Patients with Kaposi Sarcoma: A Multicenter Cohort Experience

Author

Manuela Colafigli, Sara Modica, Simona Di Giambenedetto, Ilaria Uccella, Virginia Ferraresi, Barbara Rossetti, Roberto Cauda, Arturo Ciccullo, Iuri Fanti, Alessandra Latini, Alberto Borghetti, Enza Anzalone, Emilia Migliano, Antonio Bonadies, Giordano Madeddu, Alfredo Pennica, Federico Melis, and Antonio Cristaudo

Subjects
medicine.medical_specialty, medicine.medical_treatment, Integrase inhibitor, Malignancy, Settore MED/17 - MALATTIE INFETTIVE, Article, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, 030212 general & internal medicine, acquired immunodeficiency syndrome (AIDS), 0303 health sciences, Chemotherapy, Reverse-transcriptase inhibitor, 030306 microbiology, business.industry, Incidence (epidemiology), HIV infection, Kaposi sarcoma, virus diseases, General Medicine, medicine.disease, Regimen, Cohort, Sarcoma, business, medicine.drug
Abstract

Kaposi sarcoma (KS) remains a relevant malignancy in human immunodeficiency virus (HIV)-infected patients with a non-standardized management, despite past suggestions that ritonavir-boosted protease inhibitor (bPI)-based regimens could be preferable, no combination antiretroviral therapy (cART) regimen was demonstrated to outperform the others and the impact of new drugs, drug classes or paradigms was never investigated nor proven better than previous therapeutic regimes. In order to do this, we retrospectively collected data regarding HIV-infected patients with a diagnosis of KS last seen in six Italian centers after 1 January 2013. A total of 104 KS cases in 99 patients was analyzed for 945.34 patient-year follow-up (PYFU). Twenty-six patients had visceral localizations. Thirty-three patients were treated with chemotherapy, four with electrochemotherapy, and 12 with &alpha, interferon (&alpha, IFN). At censor, 22% received a bPI-based, 14% a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based, and 28% an integrase inhibitor (INI)-based standard cART, 24% a less drug regimen and 12% a mega-cART. Twelve recurrence episodes were observed in seven patients for an incidence of 1.27 per 100 PYFU. Two patients with no evidence of recurrence episodes died for other reasons. In our experience, KS recurrence episodes were infrequent. Despite the increasing use of new antiretroviral drug classes and new treatment paradigms, no excess of recurrence episodes was observed in patients receiving such cART regimens.

Published
2019
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42. Incidence of bloodstream infections, length of hospital stay and survival in patients with recurrent Clostridioides difficile infection treated with fecal microbiota transplantation or antibiotics: a prospective cohort study

Author

Michele Impagnatiello, Gianluca Ianiro, Maurizio Sanguinetti, Graham R. Law, Luca Masucci, Massimo Fantoni, Antonio Gasbarrini, R. Murri, Roberto Cauda, Giovanni Cammarota, Giusi Desirè Sciumè, Alexander C. Ford, and Herbert Tilg

Subjects
Male, medicine.medical_specialty, A300 Clinical Medicine, genetic structures, Matched-Pair Analysis, Bacteremia, Settore MED/17 - MALATTIE INFETTIVE, Lower risk, 01 natural sciences, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, blood, Recurrence, Internal medicine, Epidemiology, Internal Medicine, medicine, Humans, 030212 general & internal medicine, 0101 mathematics, Risk factor, Prospective cohort study, Aged, Clostridioides difficile, business.industry, Incidence, Incidence (epidemiology), 010102 general mathematics, General Medicine, Fecal Microbiota Transplantation, Length of Stay, infection, Confidence interval, Anti-Bacterial Agents, Italy, Cohort, Clostridium Infections, Female, business, Cohort study
Abstract

Background: Clostridioides difficile infection (CDI) is a risk factor for bloodstream infections (BSI). Fecal microbiota transplantation (FMT) is more effective than antibiotics in treating recurrent CDI, but its efficacy in preventing CDI-related BSI is uncertain. Objective: To assess incidence of primary BSI in patients with recurrent CDI treated with FMT compared with patients treated with antibiotics. Design: Prospective cohort study. FMT and antibiotic treated patients were matched using propensity score. Setting: Single academic medical center. Patients: 290 inpatients with recurrent CDI; 57 patients per treatment in matched cohort. Interventions: FMT or antibiotics. Measurements: Our primary outcome was the development of primary BSI within a 90-day follow-up. Secondary outcomes were length of hospitalization, and overall survival (OS) at 90 days. Results: 109 patients were treated with FMT, and 181 received antibiotics. Five patients in the FMT group and 40 in the antibiotic group developed BSI. Due to differences in the patients treated with FMT and antibiotics in a number of baseline characteristics including the number of recurrences and CDI severity, comparative analyses were limited to the matched cohort. Subjects in the FMT group experienced a 23% lower risk of developing BSI (95% confidence interval 10-35%), 14 fewer days of hospitalization (95% confidence interval 9-20 days), and a 32% increase in OS (95% confidence interval 16-47%) compared with the antibiotic group. Limitations: Non-randomized study with potential for unmeasured/residual confounding. Limited generalizability of the propensity score-matched cohort. Conclusion: In a propensity score-matched cohort, patients with recurrent CDI treated with FMT were less likely to develop primary BSI.

Published
2019

43. Case Report: Multifocal Tubercular Osteomyelitis of the Spine and Bilateral Dactylitis

Author

Francesco Taccari, Giovanni Delogu, F. Pallavicini, Enrica Tamburrini, Lara Campana, Gianmaria Baldin, Roberto Cauda, Antonio Maria Leone, Michela Sali, Arianna Emiliozzi, and Edoardo Leone

Subjects
Male, medicine.medical_specialty, Adolescent, Antitubercular Agents, Settore MED/17 - MALATTIE INFETTIVE, Dactylitis, Lesion, Lumbar, Virology, medicine, Back pain, Humans, Tuberculosis, Scalp, medicine.diagnostic_test, business.industry, Osteomyelitis, Magnetic resonance imaging, Mycobacterium tuberculosis, Articles, Phalanx, medicine.disease, Hand, Spine, Surgery, Infectious Diseases, medicine.anatomical_structure, Parasitology, medicine.symptom, business, Immunocompetence
Abstract

We report a case of a 13-year-old immunocompetent male with multifocal tubercular osteomyelitis involving several spinal segments, small bones of the hands, and the scalp, who started with progressively back pain and enlarging painful swelling on the palms of hands, fatigue, and irregular fever. All the hand lesions were firm, mildly tender, and covered by ulcerated skin with serous discharge from the site. Magnetic resonance showed lesions of the right fifth metacarpal, of the right intermediate phalanx of the fourth finger, of the left second metacarpal, and of most vertebral bodies of the cervical, dorsal, lumbar, and sacral spine. The nucleic acid amplification test and the final culture from the drainage of the hands' lesion were positive for Mycobacterium tuberculosis. The patient received a standard antitubercular treatment for 12 months with clinical improvement.

Published
2019

44. A pilot experience of common European infectious diseases curriculum for medical students: the IDEAL summer school

Author

Benoît Henry, Helen Cameron, Pierre Van Damme, Joseph Ogavu, Clifford Leen, Venice Omona, I.F. Laurenson, Pauline Valnaud, Katleen de Gaetano, Erika Vlieghe, Claire Le Jeunne, Muge Cevik, Roberto Cauda, Federica I. Wolf, Caroline Charlier, Evelyn Nabankema, Benjamin Planquette, Ingolfur Johannessen, Claire L. Mackintosh, Jean-Pierre Van Geertruyden, Pierre Buffet, and University of St Andrews. School of Medicine

Subjects
Microbiology (medical), Adult, Male, Students, Medical, summer school, T-NDAS, cooperation, infectious diseases, Microbiology, Communicable Diseases, Young Adult, SDG 3 - Good Health and Well-being, Medicine, Humans, Curriculum, Biology, Schools, Medical, Medical education, Ideal (set theory), Education, Medical, business.industry, QR Microbiology, Awareness, teaching, QR, Europe, Female, business
Abstract

Postprint

Published
2019

45. Use of procalcitonin as a tool for antibiotic stewardship

Author

Massimo Fantoni, Roberto Cauda, Rita Murri, and Eleonora Taddei

Subjects
Microbiology (medical), medicine.medical_specialty, Settore MED/17 - MALATTIE INFETTIVE, Microbiology, intensive care unit, Communicable Diseases, Procalcitonin, law.invention, Sepsis, sepsis, Antimicrobial Stewardship, acute infections, Anti-Infective Agents, law, medicine, Antimicrobial stewardship, Humans, Intensive care medicine, business.industry, Bacterial Infections, medicine.disease, Intensive care unit, Intensive Care Units, Virus Diseases, Antibiotic Stewardship, antimicrobial stewardship, procalcitonin, Biomarkers, business
Published
2019

46. Risk factors for recurrence in patients with Clostridium difficile infection due to 027 and non-027 ribotypes

Author

Maurizio Sanguinetti, Paolo Carfagna, Marco Falcone, Carla Fontana, Massimo Andreoni, Paola Goldoni, Claudio Maria Mastroianni, Nicola Petrosillo, R. Murri, F. Iraci, Giusy Tiseo, Iolanda Santino, Mario Venditti, Massimo Fantoni, Roberto Cauda, Alessio Farcomeni, D. Delle Rose, Guido Antonelli, Giammarco Raponi, and Antonio Aceti

Subjects
0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Multivariate analysis, genetic structures, Settore MED/17 - Malattie Infettive, Clostridium difficile infection, Metronidazole monotherapy, Recurrence, Ribotype 027, Severe Clostridium difficile infection, Infectious Diseases, 030106 microbiology, Bacterial Toxins, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Bacterial Proteins, Internal medicine, Metronidazole, medicine, Humans, In patient, 030212 general & internal medicine, Patient group, business.industry, Clostridioides difficile, Hazard ratio, General Medicine, Clostridium difficile, Confidence interval, Anti-Bacterial Agents, Repressor Proteins, Clostridium Infections, Vancomycin, business, medicine.drug
Abstract

Our objective was to evaluate factors associated with recurrence in patients with 027+ and 027- Clostridium difficile infection (CDI).Patients with CDI observed between January and December 2014 in six hospitals were consecutively included in the study. The 027 ribotype was deduced by the presence of tcdB, tcdB, cdt genes and the deletion Δ117 in tcdC (Xpert® C. difficile/Epi). Recurrence was defined as a positive laboratory test result for C. difficile more than 14 days but within 8 weeks after the initial diagnosis date with reappearance of symptoms. To identify factors associated with recurrence in 027+ and 027- CDI, a multivariate analysis was performed in each patient group. Subdistributional hazard ratios (sHRs) and 95% confidence intervals (95%CIs) were calculated.Overall, 238 patients with 027+ CDI and 267 with 027- CDI were analysed. On multivariate analysis metronidazole monotherapy (sHR 2.380, 95%CI 1.549-3.60, p0.001) and immunosuppressive treatment (sHR 3.116, 95%CI 1.906-5.090, p0.001) were factors associated with recurrence in patients with 027+ CDI. In this patient group, metronidazole monotherapy was independently associated with recurrence in both mild/moderate (sHR 1.894, 95%CI 1.051-3.410, p 0.033) and severe CDI (sHR 2.476, 95%CI 1.281-4.790, p 0.007). Conversely, non-severe disease (sHR 3.704, 95%CI 1.437-9.524, p 0.007) and absence of chronic renal failure (sHR 16.129, 95%CI 2.155-125.000, p 0.007) were associated with recurrence in 027- CDI.Compared to vancomycin, metronidazole monotherapy appears less effective in curing CDI without relapse in the 027+ patient group, independently of disease severity.

Published
2019

47. Efficacy of Ceftazidime-Avibactam Salvage Therapy in Patients With Infections Caused by Klebsiella pneumoniae Carbapenemase-producing K. pneumoniae

Author

Alessandro Capone, Caterina Campoli, Carlo Tascini, E. Mazza, Francesco Menichetti, Claudio Viscoli, Spinello Antinori, Matteo Bassetti, Giustino Parruti, Angela Raffaella Losito, Silvia Corcione, Daniele Roberto Giacobbe, Teresa Spanu, Ercole Concia, Margherita Digaetano, Carlo Pallotto, Mario Venditti, Gennaro De Pascale, Rosario Cultrera, Enrico Maria Trecarichi, Francesco Amadori, Mario Tumbarello, Giancarlo Ceccarelli, Cristina Mussini, Francesca Raffaelli, Andrea De Gasperi, Elda Righi, Roberto Cauda, Alessandra Mularoni, Pierluigi Viale, Alberto Corona, Simona Sica, and Francesco Giuseppe De Rosa

Subjects
0301 basic medicine, Male, Microbiology (medical), Infectious Diseases, Klebsiella pneumoniae, Antibiotics, Salvage therapy, Ceftazidime, carbapenemases, ceftazidime-avibactam, KPC-producing Klebsiella pneumoniae, 0302 clinical medicine, carbapenemases, ceftazidime-avibactam, KPC-producing Klebsiella pneumoniae, 030212 general & internal medicine, biology, Middle Aged, Anti-Bacterial Agents, Drug Combinations, Treatment Outcome, Italy, Female, beta-Lactamase Inhibitors, KPC-producing Klebsiella pneumonia, medicine.drug, Adult, medicine.medical_specialty, medicine.drug_class, 030106 microbiology, Socio-culturale, Neutropenia, 03 medical and health sciences, Internal medicine, medicine, Humans, Aged, Retrospective Studies, Salvage Therapy, business.industry, Septic shock, ceftazidime-avibactam, carbapenemases, KPC-producing Klebsiella pneumonia, bacterial infections and mycoses, medicine.disease, biology.organism_classification, Ceftazidime/avibactam, Survival Analysis, Klebsiella Infections, Pneumonia, Carbapenem-Resistant Enterobacteriaceae, Bacteremia, business, Azabicyclo Compounds
Abstract

Background Ceftazidime-avibactam (CAZ-AVI) has been approved in Europe for the treatment of complicated intra-abdominal and urinary tract infections, as well as hospital-acquired pneumonia, and for gram-negative infections with limited treatment options. CAZ-AVI displays in vitro activity against Klebsiella pneumoniae carbapenemase (KPC) enzyme producers, but clinical trial data on its efficacy in this setting are lacking. Methods We retrospectively reviewed 138 cases of infections caused by KPC-producing K. pneumoniae (KPC-Kp) in adults who received CAZ-AVI in compassionate-use programs in Italy. Case features and outcomes were analyzed, and survival was then specifically explored in the large subcohort whose infections were bacteremic. Results The 138 patients started CAZ-AVI salvage therapy after a first-line treatment (median, 7 days) with other antimicrobials. CAZ-AVI was administered with at least 1 other active antibiotic in 109 (78.9%) cases. Thirty days after infection onset, 47 (34.1%) of the 138 patients had died. Thirty-day mortality among the 104 patients with bacteremic KPC-Kp infections was significantly lower than that of a matched cohort whose KPC-Kp bacteremia had been treated with drugs other than CAZ-AVI (36.5% vs 55.8%, P = .005). Multivariate analysis of the 208 cases of KPC-Kp bacteremia identified septic shock, neutropenia, Charlson comorbidity index ≥3, and recent mechanical ventilation as independent predictors of mortality, whereas receipt of CAZ-AVI was the sole independent predictor of survival. Conclusions CAZ-AVI appears to be a promising drug for treatment of severe KPC-Kp infections, especially those involving bacteremia.

Published
2019

48. Liver fibrosis is associated with cognitive impairment in people living with HIV

Author

Nicoletta Ciccarelli, Alberto Borghetti, Pierfrancesco Grima, Anna Clelia Brita, Massimiliano Fabbiani, Ramona De Marco, Simona Di Giambenedetto, Roberto Cauda, and Roberta Gagliardini

Subjects
Adult, Liver Cirrhosis, Male, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Cross-sectional study, Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, Liver fibrosis, 030106 microbiology, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, Cognitive Dysfunction, 030212 general & internal medicine, Pathological, Psychomotor learning, Coinfection, business.industry, General Medicine, Middle Aged, Hepatitis C, Cross-Sectional Studies, Infectious Diseases, Co-infection, Cognitive impairment, Fib4, Female, Transient elastography, business, Neurocognitive, Cohort study
Abstract

Our aim was to better explore the association between liver fibrosis (LF) and neurocognitive impairment (NCI) in people living with HIV (PLWH).We performed a cross-sectional cohort study by consecutively enrolling PLWH at two clinical centers. All subjects underwent a comprehensive neuropsychological battery; NCI was defined as having a pathological performance (1.5 SD below the normative mean) on at least two cognitive domains. LF was explored using FIB4 index; in a subgroup of PLWH, LF was also assessed by transient elastography.A total of 386 subjects were enrolled, of whom 17 (4.4%) had FIB4 3.25. In the subgroup of PLWH (N = 127) performing also liver transient elastography, 14 (11%) had liver stiffness 14 kPa. Overall, 47 subjects (12%) were diagnosed with NCI. At multivariate regression analyses, participants with FIB4 1.45 showed a higher risk of NCI in comparison with those with lower values (aOR 3.04, p = 0.044), after adjusting for education (aOR 0.71, p 0.001), past AIDS-defining events (aOR 2.91, p = 0.014), CD4 cell count, past injecting drug use (IDU), HIV-RNA 50 copies/mL, and HCV co-infection. Also a liver stiffness 14 kPa showed an independent association with a higher risk of NCI (aOR 10.13, p = 0.041). Analyzing any single cognitive domain, a higher risk of abnormal psychomotor speed was associated with a liver stiffness 14 kPa (aOR 223.17, p = 0.019) after adjusting for education (aOR 0.57, p = 0.018), HIV-RNA 50 copies/mL (aOR 0.01, p = 0.007), age, past IDU, and HCV co-infection.In PLWH, increased LF, estimated through non-invasive methods, was associated to a higher risk of NCI independently from HCV status.

Published
2019

49. Trends of hospitalisations rates in a cohort of HIV-infected persons followed in an Italian hospital from 1998 to 2016

Author

Simone Belmonti, Laura Camoni, Alberto Borghetti, Silvia Lamonica, Patrizio Pezzotti, Arturo Ciccullo, Gianmaria Baldin, Francesca Lombardi, Stefania Bellino, Davide Moschese, S Di Giambenedetto, and Roberto Cauda

Subjects
Adult, Male, 0301 basic medicine, medicine.medical_specialty, Epidemiology, Poisson regression model, 030106 microbiology, Human immunodeficiency virus (HIV), HIV Infections, Relative weight, Settore MED/17 - MALATTIE INFETTIVE, medicine.disease_cause, Cohort Studies, 03 medical and health sciences, symbols.namesake, 0302 clinical medicine, Risk Factors, Internal medicine, Hiv infected, Causes for hospitalisation, cohort study, HIV, hospitalisation rates, multiple failure-time data analysis, Humans, Medicine, 030212 general & internal medicine, Poisson regression, Proportional Hazards Models, Original Paper, business.industry, Proportional hazards model, Middle Aged, medicine.disease, Hospitals, Hospitalization, Infectious Diseases, Italy, Cohort, symbols, Coinfection, Female, business, Cohort study
Abstract

Here we evaluated hospitalisation rates and associated risk factors of human immunodeficiency virus (HIV)-infected individuals who were followed up in an Italian reference hospital from 1998 to 2016. Incidence rates (IR) of hospitalisations were calculated for five study periods from 1998 to 2016. The random-effects Poisson regression model was used to assess risk factors for hospitalisation including demographic and clinical characteristics. To consider that more events may occur for the same subject, multiple failure-time data analysis was also performed for selected causes using the Cox proportional hazards model. We evaluated 2031 patients. During 13 173 person-years (py) of follow-up, 3356 hospital admissions were carried out for 756 patients (IR: 255 per 1000 py). IR decreased significantly over the study period, from 634 in 1998–2000 to 126 per 1000 py in 2013–2016. Major declines were detected for AIDS-defining events, non-HIV/AIDS-related infections and neurological diseases. Older age, female sex, longer HIV duration and HCV coinfection were associated with a higher hospitalisation risk, whereas higher CD4 nadir and antiretroviral therapy were associated with a reduced risk. Influence of advanced HIV disease markers declined over time. Hospitalisation rates decreased during the study period in most causes. The relative weight of hospitalisations for non-AIDS-related tumours, cardiovascular, respiratory and kidney diseases increased during the study period, whereas those for AIDS-defining events declined.

Published
2019

50. Impact of antibiotic stewardship on perioperative antimicrobial prophylaxis

Author

Gabriele Sganga, M Tanzariello, Roberto Cauda, Paolo Parente, Walter Ricciardi, Stefano Marventano, Rita Murri, S Bucci, Massimo Fantoni, Antonio Giulio de Belvis, and Francesca Giovannenze

Subjects
Adult, Male, 0301 basic medicine, medicine.medical_specialty, Evidence-based practice, Quality management, 030106 microbiology, Cefazolin, surgical infection, excess/defect, Settore MED/17 - MALATTIE INFETTIVE, Perioperative Care, quality improvement, 03 medical and health sciences, 0302 clinical medicine, Surveys and Questionnaires, medicine, Humans, Antimicrobial stewardship, 030212 general & internal medicine, Antibiotic prophylaxis, Elective surgery, Hospitals, Teaching, Intensive care medicine, Settore MED/42 - IGIENE GENERALE E APPLICATA, Aged, business.industry, Health Policy, Public Health, Environmental and Occupational Health, antibiotic prophylaxis, General Medicine, Perioperative, Antibiotic Prophylaxis, Middle Aged, Anti-Bacterial Agents, Italy, Elective Surgical Procedures, Female, Guideline Adherence, Elective Surgical Procedure, business, medicine.drug
Abstract

Objective Antibiotic prophylaxis (AP) is useful to prevent antimicrobial overuse, misuse and abuse, as well against the occurrence of surgical site infections (SSIs). This study aimed to describe the implementation of a quality improvement intervention on AP for elective surgery, as informal interviews showed a lower than expected compliance with internal recommendations, and to evaluate intervention's effect in terms of main drug consumption. Design A quality improvement intervention on all elective cases within 14 main surgical departments was performed. SQUIRE 2.0 guidelines were used in designing and reporting. Setting The intervention was implemented in an Italian Teaching Hospital 2 years after the adoption of internal evidence-based AP recommendations. Participants Professionals involved in elective surgery. Intervention(s) The intervention was structured into two phases: a survey was conducted during two non-consecutive weeks period (April–May 2013) to assess the adherence to the international guidelines in AP; survey's results were presented and discussed with all the surgical teams (December 2013–April 2014). Main outcome measure(s) Impact on cefazolin consumption (in defined daily doses per 100 procedures). Results Data of AP for 653 surgical procedures in terms of type, timing, duration, excess and defect were analyzed. An optimal AP rate resulted in 48.1% cases. Reduction in cefazolin use (−21.5%) and cost (−22.9%) was registered. Conclusions Though results cannot be generalized to all hospital populations, the implemented intervention is likely to improve AP consequently improving quality of care and reducing costs. Further studies are needed to evaluate specific outcomes such as rate of SSIs and antibiotic resistance.

Published
2016

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