study to optimize the use of new antibiotics

Conditions: Bacterial Infections; Fungal Infection

Summary: 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: 1. 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. 2. 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. 3. 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.


Eligibility criteria:
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.

Keywords: quasi-experimental study multidrug resistant bacteria antimicrobial stewardship ceftaroline tedizolid dalbavancin ceftazidime-avibactam ceftolozane-tazobactam isavuconazole