Bacterial Infections Clinical Trial
Official title:
Quasi-experimental Intervention Study to Optimize the Use of New Antibiotics (Project 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:
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.
n/a
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