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1. Heterogeneity of treatment effect of interferon-β1b and lopinavir–ritonavir in patients with Middle East respiratory syndrome by cytokine levels

Author

Yaseen M. Arabi, Ayed Y. Asiri, Abdullah M. Assiri, Mashan L. Abdullah, Haya A. Aljami, Hanan H. Balkhy, Majed Al Jeraisy, Yasser Mandourah, Sameera AlJohani, Shmeylan Al Harbi, Hani A. Aziz Jokhdar, Ahmad M. Deeb, Ziad A. Memish, Jesna Jose, Sameeh Ghazal, Sarah Al Faraj, Ghaleb A. Al Mekhlafi, Nisreen Murad Sherbeeni, Fatehi Elnour Elzein, Frederick G. Hayden, Robert A. Fowler, Badriah M. AlMutairi, Abdulaziz Al-Dawood, and Naif Khalaf Alharbi

Subjects
Medicine, Science
Abstract

Abstract Animal and human data indicate variable effects of interferons in treating coronavirus infections according to inflammatory status and timing of therapy. In this sub-study of the MIRACLE trial (MERS-CoV Infection Treated with a Combination of Lopinavir–Ritonavir and Interferon β-1b), we evaluated the heterogeneity of treatment effect of interferon-β1b and lopinavir–ritonavir versus placebo among hospitalized patients with MERS on 90-day mortality, according to cytokine levels and timing of therapy. We measured plasma levels of 17 cytokines at enrollment and tested the treatment effect on 90-day mortality according to cytokine levels (higher versus lower levels using the upper tertile (67%) as a cutoff point) and time to treatment (≤ 7 days versus > 7 days of symptom onset) using interaction tests. Among 70 included patients, 32 received interferon-β1b and lopinavir–ritonavir and 38 received placebo. Interferon-β1b and lopinavir–ritonavir reduced mortality in patients with lower IL-2, IL-8 and IL-13 plasma concentrations but not in patients with higher levels (p-value for interaction = 0.09, 0.07, and 0.05, respectively) and with early but not late therapy (p = 0.002). There was no statistically significant heterogeneity of treatment effect according to other cytokine levels. Further work is needed to evaluate whether the assessment of inflammatory status can help in identifying patients with MERS who may benefit from interferon-β1b and lopinavir–ritonavir. Trial registration: This is a sub-study of the MIRACLE trial (ClinicalTrials.gov number, NCT02845843).

Published
2022
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2. Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial

Author

Yaseen M. Arabi, Ayed Y. Asiri, Abdullah M. Assiri, Hani A. Aziz Jokhdar, Adel Alothman, Hanan H. Balkhy, Sameera AlJohani, Shmeylan Al Harbi, Suleiman Kojan, Majed Al Jeraisy, Ahmad M. Deeb, Ziad A. Memish, Sameeh Ghazal, Sarah Al Faraj, Fahad Al-Hameed, Asim AlSaedi, Yasser Mandourah, Ghaleb A. Al Mekhlafi, Nisreen Murad Sherbeeni, Fatehi Elnour Elzein, Abdullah Almotairi, Ali Al Bshabshe, Ayman Kharaba, Jesna Jose, Abdulrahman Al Harthy, Mohammed Al Sulaiman, Ahmed Mady, Robert A. Fowler, Frederick G. Hayden, Abdulaziz Al-Dawood, Mohamed Abdelzaher, Wail Bajhmom, Mohamed A. Hussein, and and the Saudi Critical Care Trials group

Subjects
Coronavirus, MERS, Antiviral, Clinical trial, Lopinavir/ritonavir, Interferon-β1b, Medicine (General), R5-920
Abstract

Abstract The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment. Trial registration ClinicalTrials.gov, NCT02845843. Registered on 27 July 2016.

Published
2020
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3. Author response for 'Type I interferon autoantibodies in hospitalized patients with Middle East respiratory syndrome and association with outcomes and treatment effect of interferon beta‐1b in MIRACLE clinical trial'

Author

null Faizah Alotaibi, null Naif Khalaf Alharbi, null Lindsey B. Rosen, null Ayed Y. Asiri, null Abdullah M. Assiri, null Hanan H. Balkhy, null Majed Al Jeraisy, null Yasser Mandourah, null Sameera AlJohani, null Shmeylan Al Harbi, null Hani A. Aziz Jokhdar, null Ahmad M. Deeb, null Ziad A. Memish, null Jesna Jose, null Sameeh Ghazal, null Sarah Al Faraj, null Ghaleb A. Al Mekhlafi, null Nisreen Murad Sherbeeni, null Fatehi Elnour Elzein, null Badriah M. AlMutairi, null Abdulaziz Al‐Dawood, null Mashan L. Abdullah, null Tlili Barhoumi, null Mohammed W. Alenazi, null Abdulrahman Almasood, null Steven M. Holland, null Yaseen M. Arabi, and null the Saudi Critical Care Trials Group

Published
2023

4. Randomized Controlled Multicenter Clinical Study Evaluating Crestal Bone Level Change of Narrow-Diameter Versus Standard-Diameter Ti-Zr Implants for Single Tooth Replacement in Anterior and Premolar Region

Author

Saba Sameeh Ghazal, Tara Aghaloo, Robert B. O'Neal, David L. Cochran, Stuart J. Froum, Guy Huynh-Ba, and Serge Dibart

Subjects
business.industry, Dentistry, 030206 dentistry, 02 engineering and technology, General Medicine, 021001 nanoscience & nanotechnology, Bone remodeling, law.invention, 03 medical and health sciences, 0302 clinical medicine, medicine.anatomical_structure, Patient satisfaction, Randomized controlled trial, law, Maxilla, Premolar, medicine, Implant, Oral Surgery, medicine.symptom, 0210 nano-technology, business, Prospective cohort study, Gingival recession
Abstract

Purpose The purpose of this prospective randomized clinical trial was to test the hypothesis that narrow-diameter titanium-zirconium (Ti-Zr) alloy implants with a chemically modified hydrophilic surface are not inferior in regard to crestal bone level change compared with standard-diameter implants with the same implant surface and material (control). Materials and methods This multicenter study included 50 patients in need of a single tooth replacement in the anterior (canine to canine) or premolar region of the mandible or maxilla. Patients were included if the site could accommodate a 4.1-mm-diameter implant. Implants were temporarily restored at 3 to 4 weeks after placement. Definitive restorations were delivered 4 to 6 months after placement. Patients returned 1 year after implant loading for clinical measurements and radiographic examination. The primary outcome was mean crestal bone level changes measured between implant loading and 12 months postloading. Secondary outcomes included implant success, survival, gingival recession, and patient satisfaction. Results Fifty patients were enrolled; 47 completed the study. Twenty-three patients were in the narrow-diameter implant group (test), and 24 patients were in the standard-diameter implant group (control). The success and survival rates at 12 months postloading were 100% for both groups. The change in the mean crestal bone level from implant loading to 12 months postloading around narrow-diameter implants was -0.27 ± 0.34 mm. For the standard-diameter implants, the change was significantly higher at -0.48 ± 0.67 mm (P = .02). No significant difference was found in gingival recession and patient satisfaction. Conclusion The results of this prospective randomized clinical trial suggest noninferiority of the narrow- vs standard-diameter Ti-Zr implant. In addition, bone remodeling was less pronounced for the narrow-diameter implants.

Published
2019

5. A Randomized, Controlled, Multicenter Clinical Study Evaluating The Crestal Bone Level Change Of SLActive Bone Level Ø 3.3 mm Implants Compared To SLActive Bone Level Ø 4.1 mm Implants For Single-Tooth Replacement

Author

Saba Sameeh, Ghazal, Guy, Huynh-Ba, Tara, Aghaloo, Serge, Dibart, Stuart, Froum, Robert, O'Neal, and David, Cochran

Subjects
Adult, Dental Implants, Male, Titanium, Dental Implantation, Endosseous, Mandible, Middle Aged, Dental Implants, Single-Tooth, Dental Prosthesis Design, Maxilla, Humans, Bicuspid, Female, Prospective Studies, Zirconium, Aged
Abstract

The purpose of this prospective randomized clinical trial was to test the hypothesis that narrow-diameter titanium-zirconium (Ti-Zr) alloy implants with a chemically modified hydrophilic surface are not inferior in regard to crestal bone level change compared with standard-diameter implants with the same implant surface and material (control).This multicenter study included 50 patients in need of a single tooth replacement in the anterior (canine to canine) or premolar region of the mandible or maxilla. Patients were included if the site could accommodate a 4.1-mm-diameter implant. Implants were temporarily restored at 3 to 4 weeks after placement. Definitive restorations were delivered 4 to 6 months after placement. Patients returned 1 year after implant loading for clinical measurements and radiographic examination. The primary outcome was mean crestal bone level changes measured between implant loading and 12 months postloading. Secondary outcomes included implant success, survival, gingival recession, and patient satisfaction.Fifty patients were enrolled; 47 completed the study. Twenty-three patients were in the narrow-diameter implant group (test), and 24 patients were in the standard-diameter implant group (control). The success and survival rates at 12 months postloading were 100% for both groups. The change in the mean crestal bone level from implant loading to 12 months postloading around narrow-diameter implants was -0.27 ± 0.34 mm. For the standard-diameter implants, the change was significantly higher at -0.48 ± 0.67 mm (P = .02). No significant difference was found in gingival recession and patient satisfaction.The results of this prospective randomized clinical trial suggest noninferiority of the narrow- vs standard-diameter Ti-Zr implant. In addition, bone remodeling was less pronounced for the narrow-diameter implants.

Published
2019

6. Predictors of MERS-CoV infection: A large case control study of patients presenting with ILI at a MERS-CoV referral hospital in Saudi Arabia

Author

Sameeh Ghazal, Saleh A. Aloqiel, Amal M. Mohamed, Talal A. Altuwaijri, Fahad Bafaqeeh, Kamel Aldosari, Sarah H. Alfaraj, Ziad A. Memish, Donna K. McClish, Hamzah A. Mohd, Ahmed M. Alenzi, and Marzouqah S. Alanazi

Subjects
Adult, Male, 0301 basic medicine, Pediatrics, medicine.medical_specialty, Referral, Middle East Respirator Syndrome, viruses, 030106 microbiology, Saudi Arabia, Real-Time Polymerase Chain Reaction, Article, MERS-CoV, 03 medical and health sciences, 0302 clinical medicine, Predictive Value of Tests, Internal medicine, medicine, Humans, In patient, 030212 general & internal medicine, Mortality, Respiratory system, Referral and Consultation, Cross Infection, Predictors, business.industry, X-Rays, Mortality rate, Public Health, Environmental and Occupational Health, Case-control study, virus diseases, Wbc count, Middle Aged, Thorax, respiratory tract diseases, Coronavirus, Infectious Diseases, Case-Control Studies, Middle East Respiratory Syndrome Coronavirus, Absolute neutrophil count, Female, Coronavirus Infections, business
Abstract

Summary Background A case control study to better characterize the clinical features, laboratory, and radiological abnormalities associated with MERS-CoV infection in order to help with early identification of this syndrome from other respiratory infections. Methods Eighty patients admitted to a hospital in Riyadh, diagnosed with MERS-CoV infection based on RT-PCR were matched on age, sex, and the presence of a co-morbid condition on a basis of 1:2 to other patients admitted with respiratory symptoms and tested negative for MERS-CoV on RT-PCR. Results None of the reported MERS-CoV presenting symptoms was significantly associated with being infected with MERS-CoV. On the other hand, WBC count was significantly lower in patients with confirmed MERS-CoV infection (median 5.7 vs 9.3, P: 0.0004). Neutrophil count was as well significantly lower in MERS-CoV patients (median 3.7 vs 6.7, P: 0.0001). Both AST, and ALT values were significantly higher in MERS-CoV infected group (AST median 42 vs 36, P: 0.03, and ALT median 33 vs 28, P: 0.003). Overall our MERS-CoV mortality rate was (10%) below the national figure of (40%). Conclusions None of the presenting symptoms are specific for MERS-CoV infection. And out of all the investigations WBC, neutrophil counts, AST and ALT values have some predictive utility.

Published
2016

7. International Nosocomial Infection Control Consortium (INICC) report, data summary of 36 countries, for 2004-2009

Author

Victor D, Rosenthal, Hu, Bijie, Dennis G, Maki, Yatin, Mehta, Anucha, Apisarnthanarak, Eduardo A, Medeiros, Hakan, Leblebicioglu, Dale, Fisher, Carlos, Álvarez-Moreno, Ilham Abu, Khader, Marisela, Del Rocío González Martínez, Luis E, Cuellar, Josephine Anne, Navoa-Ng, Rédouane, Abouqal, Humberto, Guanche Garcell, Zan, Mitrev, María Catalina, Pirez García, Asma, Hamdi, Lourdes, Dueñas, Elsie, Cancel, Vaidotas, Gurskis, Ossama, Rasslan, Altaf, Ahmed, Souha S, Kanj, Olber Chavarría, Ugalde, Trudell, Mapp, Lul, Raka, Cheong, Yuet Meng, Le Thi Anh, Thu, Sameeh, Ghazal, Achilleas, Gikas, Leonardo Pazmiño, Narváez, Nepomuceno, Mejía, Nassya, Hadjieva, May Osman, Gamar Elanbya, María Eugenia, Guzmán Siritt, Kushlani, Jayatilleke, Roswitha, Wolfram, OMÜ, Rosenthal, VD, Sakarya Üniversitesi/Tıp Fakültesi/Dahili Tıp Bilimleri Bölümü, and Güçlü, Ertuğrul

Subjects
Male, Imipenem, Epidemiology, Antibiotic resistance, International Cooperation, Ceftazidime, Network, intensive care unit, law.invention, Nosocomial infection, law, Prevalence, Infection control, Prospective Studies, ceftazidime, Child, Aged, 80 and over, catheter infection, Cross Infection, Urinary tract infection, Health Policy, Ventilator-associated pneumonia, article, Bacterial Infections, Middle Aged, Intensive care unit, infection control, Device-associated infection, Low-income countries, Europe, Intensive Care Units, Klebsiella pneumoniae, Infectious Diseases, Child, Preschool, Pseudomonas aeruginosa, Central line-associated bloodstream infection, Limited-resources countries, Female, disease surveillance, medicine.drug, hospitalization, prospective study, Adult, meticillin, medicine.medical_specialty, Staphylococcus aureus, Asia, Adolescent, Health care-associated infection, Catheter-associated urinary tract infection, bloodstream infection, Bloodstream infection, South and Central America, Developing countries, Young Adult, Internal medicine, Intensive care, medicine, Escherichia coli, Humans, Hospital infection, human, Intensive care medicine, Aged, nonhuman, Bacteria, business.industry, bacterium isolate, Infant, Newborn, Public Health, Environmental and Occupational Health, developing country, Infant, medicine.disease, Nosocomial infection control, mortality, hospital bed, Latin America, Africa, ventilator associated pneumonia, business
Abstract

Medeiros, Eduardo A/0000-0002-6205-259X; Garcell, Humberto Guanche/0000-0001-7279-0062; Leblebicioglu, Hakan/0000-0002-6033-8543; Dikmen, Yalim/0000-0002-3122-5099; Abouqal, Redouane/0000-0002-6117-4341; Kendirli, Tanil/0000-0001-9458-2803; Tsioutis, Constantinos/0000-0002-7865-8529; Yalcin, Ata Nevzat/0000-0002-7243-7354; Abouqal, Redouane/0000-0002-6117-4341; Acar, Ali/0000-0003-2008-5112; alvarez Moreno, carlos Arturo/0000-0001-5419-4494; Ozdemir, Halil/0000-0002-7318-1688; Satti, Asim/0000-0001-8432-6101; Barahona G., Nayide/0000-0003-3559-6900; Gikas, Achilleas/0000-0002-8455-9631; Mitrev, Zan/0000-0001-7859-8821; Jayatilleke, Kushlani/0000-0002-3931-6630; Unal, Necmettin/0000-0002-9440-7893; Kanj, Souha/0000-0001-6413-3396; Gonzalez Martinez, Marisela del Rocio/0000-0003-1474-736X; Rodriguez Ferrer, Marena Luz/0000-0002-8053-8454 WOS: 000304378300003 PubMed: 21908073 The results of a surveillance study conducted by the International Nosocomial Infection Control Consortium (INICC) from January 2004 through December 2009 in 422 intensive care units (ICUs) of 36 countries in Latin America, Asia, Africa, and Europe are reported. During the 6-year study period, using Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN; formerly the National Nosocomial Infection Surveillance system [NNIS]) definitions for device-associated health care-associated infections, we gathered prospective data from 313,008 patients hospitalized in the consortium's ICUs for an aggregate of 2,194,897 ICU bed-days. Despite the fact that the use of devices in the developing countries' ICUs was remarkably similar to that reported in US ICUs in the CDC's NHSN, rates of device-associated nosocomial infection were significantly higher in the ICUs of the INICC hospitals; the pooled rate of central line-associated bloodstream infection in the INICC ICUs of 6.8 per 1,000 central line-days was more than 3-fold higher than the 2.0 per 1,000 central line-days reported in comparable US ICUs. The overall rate of ventilator-associated pneumonia also was far higher (15.8 vs 3.3 per 1,000 ventilator-days), as was the rate of catheter-associated urinary tract infection (6.3 vs. 3.3 per 1,000 catheter-days). Notably, the frequencies of resistance of Pseudomonas aeruginosa isolates to imipenem (47.2% vs 23.0%), Klebsiella pneumoniae isolates to ceftazidime (76.3% vs 27.1%), Escherichia coli isolates to ceftazidime (66.7% vs 8.1%), Staphylococcus aureus isolates to methicillin (84.4% vs 56.8%), were also higher in the consortium's ICUs, and the crude unadjusted excess mortalities of device-related infections ranged from 7.3% (for catheter-associated urinary tract infection) to 15.2% (for ventilator-associated pneumonia). Copyright (C) 2011 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Published
2012

8. Understanding the knowledge and attitude of prehospital sepsis care among emergency medical service personnel

Author

Hadeel Sameeh Ghazal, Atheer Abdulaziz Alkhunein, Ahmed Abdullah Alkhazi, Salman Abdulmajeed Aldeheshi, Faisal Ahmed M. Alhusain, and Nawfal Al Jerian

Subjects
Emergency medical services, knowledge, prehospital, sepsis, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

Background: Sepsis represents a huge burden for the health-care system. Septic patients presented by emergency medical services (EMS) are usually sicker in comparison to patients arriving by other means. Knowledge of sepsis is a key factor in recognizing and providing the appropriate care; it is not the only barrier as EMS providers do not have access to the proper diagnostic investigation. This work highlighted the level of knowledge, awareness, and attitude of EMS providers regarding prehospital care of sepsis in Riyadh, Saudi Arabia. Methods: This study was a cross-sectional study that conducted among EMS personnel of Saudi Red Crescent Authority and King Abdulaziz Medical City. One hundred and ninety-seven individuals were sampled (99 were technicians and 98 were paramedics). Results: Most participants (71%) were aware of the term “sepsis;” however, only 48% of participants correctly defined sepsis (30% between emergency medical technicians [EMTs] vs. 66% paramedics group,P < 0.01). Paramedics were noted to have a better understanding of signs, symptoms, and management of sepsis. Most of the participants thought that sepsis can be identified during prehospital care (55%) and 75% suggested that they should be involved in the management of septic patients. About 80% responded that their intervention would result in a better outcome for patients and would influence the behavior of emergency department medical care. Most of the participants (83%) were willing to be actively engaged in the prehospital care of septic patients. Conclusion: This study showed an insufficient level of knowledge and awareness regarding sepsis care in the EMS field in Saudi Arabia. Paramedics had more knowledge and awareness about sepsis care compared to EMT personnel. Future work should focus on exploring the reasons behind this, as well as implementing plans to improve education about sepsis for EMS personnel.

Published
2019
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