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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
900
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.
Hospital de Poniente-El Ejido
Almería, Spain
SUSPENDEDUniversity Hospital Puerta del Mar
Cadiz, Spain
RECRUITINGUniversity Hospital Reina Sofía
Córdoba, Spain
RECRUITINGHospital Clínico Universitario San Cecilio
Granada, Spain
RECRUITINGUniversity Hospital Virgen de las Nieves
Granada, Spain
RECRUITINGÁrea Hospitalaria Juan Ramón Jiménez
Huelva, Spain
RECRUITINGComplejo Hospitalario de Jaén
Jaén, Spain
RECRUITINGUniversity Hospital de Jerez de la Frontera
Jerez de la Frontera, Spain
RECRUITINGHospital Regional Universitario de Málaga
Málaga, Spain
RECRUITINGUniversity Hospital Virgen de la Victoria
Málaga, Spain
RECRUITING...and 4 more locations
Total antibiotic consumption
Defined daily doses (DDD) of each antibiotic per 1000 stays
Time frame: Yearly from date of intervention up to 24 months of follow-up
Total cost per antimicrobial
Total expense in euros of each antimicrobial per 1000 stays
Time frame: Yearly from date of intervention up to 24 months of follow-up
Mortality rate
Mortality from any cause at 7, 14 and 30 days after the start of the treatment.
Time frame: At 7, 14 and 30 days after the start of the treatment.
Total length of hospital stay
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.
Time frame: Monthly from date of intervention up to 24 months of follow-up
Incidence of colitis due to Clostridium difficile.
Clostridium difficile infection documented during treatment with any of the antibiotics described
Time frame: Monthly from date of intervention up to 24 months of follow-up
Percentage of patients with infections by multiresistant microorganisms. Colonization during treatment by resistant microorganisms
Percentage of patients with infections by multiresistant microorganisms in each cohort.
Time frame: Monthly from date of intervention up to 24 months of follow-up
Percentage of patients colonized by multiresistant microorganisms
Percentage of patients colonized by multiresistant microorganisms in each cohort after completion of treatment with antibiotic under study.
Time frame: Monthly from date of intervention up to 24 months of follow-up
Re-admission rate
Re-admission of the patient in the hospital at 90 days after the start of the antibiotic treatment.
Time frame: 90 days after the start of the antibiotic treatment.
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