Study to Optimize the Use of New Antibiotics (NEW_SAFE)

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    900
  • sponsor
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Updated on 16 February 2022
antibiotic therapy
antibiotics
bacteremia
carbapenem
methicillin
vancomycin
dalbavancin
ceftazidime
antimicrobials
staphylococcus
tedizolid
ceftazidime-avibactam
isavuconazole

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.

Details
Condition Bacterial Infections, Fungal Infection
Treatment Non-impositive Program for Optimizing the Use of Antimicrobials
Clinical Study IdentifierNCT03941951
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

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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