Bacterial Infections, Fungal Infection
Conditions
Keywords
Quasi-experimental study, Multidrug resistant bacteria, Antimicrobial stewardship, Ceftaroline, Tedizolid, Dalbavancin, Ceftazidime-avibactam, Ceftolozane-tazobactam, Isavuconazole
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.
Interventions
BEHAVIORALNon-impositive Program for Optimizing the Use of Antimicrobials
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.
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The prescribers are assigned to receive the intervention if they have prescribed any of the antibiotics ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole from January 2010 to June 2021.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
Countries
Spain
Contacts
Primary ContactZaira Palacios Baena
Backup ContactPilar Retamar Gentil
Outcome results
None listed