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OBJECTIVES: To evaluate the appropriateness of ceftazidime-avibactam (C-A), ceftolozane-tazobactam (C-T) and ceftaroline prescriptions according to European Medicines Agency (EMA)/Spanish Agency of Medicines and Medical Devices (AEMPS) approved indications, financed indications in the Spanish health system and hospital Infection Commission (IC) recommendations in a tertiary hospital. METHODS: Observational, descriptive and retrospective study of inpatients aged ≥18 years, who were prescribed the above-mentioned antimicrobials during the period January–December 2020. Variables obtained were demographic (sex and age), pharmacological (antibiotic, use – empiric or targeted, indication) and microbiological (sensitivity testing and antibiotic tested) data. RESULTS: A total of 79 patients were included. C-A (n=40): 67.5% of patients were male, with a mean age of 61 (range 22–87) years. Empiric treatment was applied in 30% of the cases (n=12). De-escalation in 33.33% of individuals. Sensitivity testing was done in 92.86% of patients, including C-A in 57.69% of them. C-T (n=19): 89.47% of patients were male, with a mean age of 65 (range 18–82) years. An empiric approach was followed in 5.26% of subjects; de-escalation was performed in all cases due to culture with multidrug-resistant (MDR) Pseudomonas aeruginosa. Sensitivity testing was carried out in 100% of patients, including C-T in 26.32% of them. Ceftaroline (n=20): 70% of patients were male, with a mean age of 55.5 (range 23–79) years. Empiric treatment was applied to 30% of cases. In 50% of these subjects de-escalation was done. Sensitivity testing was done in 92.85% of them, but in none with ceftaroline. Regarding the percentage of appropriateness: approved EMA/AEMPS indications: C-A: 100%; C-T: 84.21%; ceftaroline: 75%; financed indications in the Spanish health system: C-A: 85%; C-T: 100%; ceftaroline: 15%; IC: C-A: 60%; C-T: 57.9%; ceftaroline: 15%. CONCLUSIONS: Our results highlight the importance of stewardship programmes in the decision-making process and in the follow-up of patients with infections caused by MDR microorganisms.

Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Complicacions infeccioses; Càncer Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Complicaciones infecciosas; Cáncer Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Infectious complications; Cancer Background We aimed to describe the epidemiology, risk factors, and clinical outcomes of co-infections and superinfections in onco-hematological patients with COVID-19. Methods International, multicentre cohort study of cancer patients with COVID-19. All patients were included in the analysis of co-infections at diagnosis, while only patients admitted at least 48 h were included in the analysis of superinfections. Results 684 patients were included (384 with solid tumors and 300 with hematological malignancies). Co-infections and superinfections were documented in 7.8% (54/684) and 19.1% (113/590) of patients, respectively. Lower respiratory tract infections were the most frequent infectious complications, most often caused by Streptococcus pneumoniae and Pseudomonas aeruginosa . Only seven patients developed opportunistic infections. Compared to patients without infectious complications, those with infections had worse outcomes, with high rates of acute respiratory distress syndrome, intensive care unit (ICU) admission, and case-fatality rates. Neutropenia, ICU admission and high levels of C-reactive protein (CRP) were independent risk factors for infections. Conclusions Infectious complications in cancer patients with COVID-19 were lower than expected, affecting mainly neutropenic patients with high levels of CRP and/or ICU admission. The rate of opportunistic infections was unexpectedly low. The use of empiric antimicrobials in cancer patients with COVID-19 needs to be optimized. This study was supported by the Spanish Plan Nacional de IDi 2013-2016, Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Economía, Industria y Competitividad, and the Spanish Network for Research in Infectious Diseases (REIPI grant: RD16/0016/0001). It was also co-financed by the European Development Regional Fund ‘A Way to Make Europe’, Operational Programme Smart Growth 2014-2020.

[Objective] To prove that 7-day courses of antibiotics for bloodstream infections caused by members of the Enterobacterales (eBSIs) allow a reduction in patients' exposure to antibiotics while achieving clinical outcomes similar to those of 14-day schemes., [Methods] A randomized trial was performed. Adult patients developing eBSI with appropriate source control were assigned to 7 or 14 days of treatment, and followed 28 days after treatment cessation; treatments could be resumed whenever necessary. The primary endpoint was days of treatment at the end of follow-up. Clinical outcomes included clinical cure, relapse of eBSI and relapse of fever. A superiority margin of 3 days was set for the primary endpoint, and a non-inferiority margin of 10% was set for clinical outcomes. Efficacy and safety were assessed together with a DOOR/RADAR (desirability of outcome ranking and response adjusted for duration of antibiotic risk) analysis., [Results] 248 patients were assigned to 7 (n = 119) or 14 (n = 129) days of treatment. In the intention-to-treat analysis, median days of treatment at the end of follow-up were 7 and 14 days (difference 7, 95%CI 7–7). The non-inferiority margin was also met for clinical outcomes, except for relapse of fever (–0.2%, 95%CI –10.4 to 10.1). The DOOR/RADAR showed that 7-day schemes had a 77.7% probability of achieving better results than 14-day treatments., [Conclusions] 7-day schemes allowed a reduction in antibiotic exposure of patients with eBSI while achieving outcomes similar to those of 14-day schemes. The possibility of relapsing fever in a limited number of patients, without relevance to final outcomes, may not be excluded, but was overcome by the benefits of shortening treatments., This work received technical support from the Spanish Network of Research in Infectious Diseases (REIPI) and the Spanish Clinical Research Network (SCReN) of the Instituto de Salud Carlos III, Ministerio de Economía y Competitividad, Spanish Government (PT13/0002/0010).

Introduction Pseudomonas aeruginosa (PA) has historically been one of the major causes of severe sepsis and death among neutropenic cancer patients. There has been a recent increase of multidrug-resistant PA (MDRPA) isolates that may determine a worse prognosis, particularly in immunosuppressed patients. The aim of this study is to establish the impact of antibiotic resistance on the outcome of neutropenic onco-haematological patients with PA bacteraemia, and to identify the risk factors for MDRPA bacteraemia and mortality. Methods and analysis This is a retrospective, observational, multicentre, international study. All episodes of PA bacteraemia occurring in neutropenic onco-haematological patients followed up at the participating centres from 1 January 2006 to 31 May 2018 will be retrospectively reviewed. The primary end point will be overall case-fatality rate within 30 days of onset of PA bacteraemia. The secondary end points will be to describe the following: the incidence and risk factors for multidrug-resistant and extremely drug-resistant PA bacteraemia (by comparing the episodes due to susceptible PA with those produced by MDRPA), the efficacy of ceftolozane/tazobactam, the rates of persistent bacteraemia and bacteraemia relapse and the risk factors for very early (48 hours), early (7 days) and overall (30 days) case-fatality rates. Ethics and dissemination The Clinical Research Ethics Committee of Bellvitge University Hospital approved the protocol of the study at the primary site. To protect personal privacy, identifying information of each patient in the electronic database will be encrypted. The processing of the patients’ personal data collected in the study will comply with the Spanish Data Protection Act of 1998 and with the European Directive on the privacy of data. All data collected, stored and processed will be anonymised. Results will be reported at conferences and in peer-reviewed publications.