Study to Optimize the Use of New Antibiotics (NEW_SAFE)

Quasi-experimental intervention multicenter trial of patients treated with new antibiotics (before-after study). The study will be carried out in 14 hospitals of the Andalusian Public Health System with representation from all the provinces and has been designed in two phases: A first phase in which an observational study of historical preintervention cohorts of patients who have received either empirical or targeted treatment with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam and isavuconazole from January 2016 to December 2019 will be developed. Case detection will be carried out by locating the antimicrobial prescriptions in the electronic prescribing systems and / or pharmaceutical management systems of each hospital. A set of epidemiological, clinical, microbiological and prognostic variables will be completed in each case. A second phase or intervention period that will be applied to the cohort of patients treated with new antibiotics (intervention cohort) from January 2020 to June 2021. A quasi-experimental intervention study will be carried out through the development of a Program for Optimizing the use of Antibiotics (PROA) in Spanish, Antimicrobial Stewardship Program (ASP) in English, in the participating hospitals. It will consist in the development of a consensus document on the use of new antibiotics following a Delphi methodology, dissemination of the consensus document / guide among the participating hospitals and audit on the prescription of new antimicrobials after the implementation of the guide based on providing non-imposition advice and positive reinforcement to the prescriber. The recommendations will be consigned in a structured form, which will allow to evaluate the degree of follow-up of the recommendations. The audit will be performed on day 0-1 of the prescription. Cohort of bacteremia due to multiresistant microorganisms ("safety" cohort): In order to evaluate the safety of the use of new antimicrobials against therapeutic alternatives in syndromes where they are potentially a preferred option and parallel to the two phases, episodes for bacteremia by carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa, carbapenem-resistant enterobacteria, vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus occurred in participating hospitals from 2017 to 2021 will be collected.

Quasi-experimental study, Multidrug resistant bacteria, Antimicrobial stewardship, Ceftaroline, Tedizolid, Dalbavancin, Ceftazidime-avibactam, Ceftolozane-tazobactam, Isavuconazole

The prescribers are assigned to receive the intervention if they have prescribed any of the antibiotics ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole from January 2010 to June 2021.

Cohort of patients who have received either empirical or targeted treatment with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole from January 2016 to December 2019 will be included.

Cohort of patients with complex infections treated with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole from January 2010 to June 2021.

Cohort of patients with bacteremia due to carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa, carbapenem-resistant enterobacteria, vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus occurred in participating hospitals from 2017 to 2021 will be collected.

Quasi-experimental intervention through the development of a Program for Optimizing the Use of Antimicrobials in the participating hospitals. The intervention will consist of the development of a consensus guide on the use of new antibiotics, its dissemination in Andalusian hospitals and an audit on the prescription of new antibiotics.

Duration of a single episode of hospitalization defined as the time between hospital admission and discharge measured in days. During this episode the patient has to be prescribed with one of the antibiotics included in the study.

Percentage of patients with infections by multiresistant microorganisms. Colonization during treatment by resistant microorganisms

Percentage of patients colonized by multiresistant microorganisms in each cohort after completion of treatment with antibiotic under study.

Pre-intervention cohort (historical): Inclusion criteria: All patients treated with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole. In a hospital or ambulatory regime. That they have received at least 1 dose of treatment of any of the antimicrobials mentioned, either as empirical or directed treatment. Adults (18 years). Between January 1, 2016 and December 31, 2019. Exclusion criteria: • There are no exclusion criteria except for age. Intervention cohort: Inclusion criteria: All patients treated with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole. In a hospital or ambulatory regime. That they have received at least 1 dose of treatment of any of the antimicrobials mentioned, either as empirical or directed treatment. Adults (18 years). From January 1, 2020 to December 31, 2021. Since the publication and diffusion of the recommendation guide. Exclusion criteria: • There are no exclusion criteria except for age. Safety cohort: Inclusion criteria: All episodes of clinically significant bacteremia (that have received any treatment) produced by: Acinetobacter baumannii resistant or with intermediate susceptibility to any carbapenem. Pseudomonas aeruginosa resistant or with intermediate susceptibility to any carbapenem. Enterobacteria resistant or with intermediate susceptibility to any carbapenem. Vancomycin-resistant Enterococcus faecium. Methicillin-resistant Staphylococcus aureus. From January 1, 2017 to December 31, 2021. Adult patients (18 years old). Exclusion criteria: • There are no exclusion criteria except for age.

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