Study to Optimize the Use of New Antibiotics
- Conditions
- Fungal InfectionBacterial Infections
- Interventions
- Behavioral: Non-impositive Program for Optimizing the Use of Antimicrobials
- Registration Number
- NCT03941951
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 900
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention cohort Non-impositive Program for Optimizing the Use of Antimicrobials Cohort of patients with complex infections treated with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole from January 2010 to June 2021.
- Primary Outcome Measures
Name Time Method Total antibiotic consumption Yearly from date of intervention up to 24 months of follow-up Defined daily doses (DDD) of each antibiotic per 1000 stays
- Secondary Outcome Measures
Name Time Method Total cost per antimicrobial Yearly from date of intervention up to 24 months of follow-up Total expense in euros of each antimicrobial per 1000 stays
Incidence of colitis due to Clostridium difficile. Monthly from date of intervention up to 24 months of follow-up Clostridium difficile infection documented during treatment with any of the antibiotics described
Percentage of patients colonized by multiresistant microorganisms Monthly from date of intervention up to 24 months of follow-up Percentage of patients colonized by multiresistant microorganisms in each cohort after completion of treatment with antibiotic under study.
Total length of hospital stay Monthly from date of intervention up to 24 months of follow-up 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 Monthly from date of intervention up to 24 months of follow-up Percentage of patients with infections by multiresistant microorganisms in each cohort.
Mortality rate At 7, 14 and 30 days after the start of the treatment. Mortality from any cause at 7, 14 and 30 days after the start of the treatment.
Re-admission rate 90 days after the start of the antibiotic treatment. Re-admission of the patient in the hospital at 90 days after the start of the antibiotic treatment.
Trial Locations
- Locations (14)
University Hospital Virgen de Valme
🇪🇸Sevilla, Spain
University Hospital Puerta del Mar
🇪🇸Cadiz, Spain
Área Hospitalaria Juan Ramón Jiménez
🇪🇸Huelva, Spain
University Hospital Reina Sofía
🇪🇸Córdoba, Spain
Hospital Clínico Universitario San Cecilio
🇪🇸Granada, Spain
Hospital de Poniente-El Ejido
🇪🇸Almería, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Hospital de Puerto Real
🇪🇸Puerto Real, Spain
University Hospital de Jerez de la Frontera
🇪🇸Jerez De La Frontera, Spain
University Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
University Hospital Virgen de las Nieves
🇪🇸Granada, Spain
University Hospital Virgen Macarena (Sevilla).
🇪🇸Sevilla, Spain
University Hospital Virgen del Rocío
🇪🇸Sevilla, Spain