Safer antibiotic use in adult intensive care units
Official title: Estudo de Implementação de Melhoria de Qualidade Para Redução do Uso de Antimicrobianos em Unidades de Terapia Intensiva
Run by Hospital Sirio-Libanes · NCT07093450 · Data updated 2026-11-12
This project will try an educational program with audit-and-feedback for ICU clinicians to see if it reduces antibiotic use in adult patients in Brazilian intensive care units while keeping ICU death rates and length of stay stable.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 9000 (estimated) |
| Sponsor | Hospital Sirio-Libanes Academic / other |
| Locations | 9 sites (Colatina, Espírito Santo and 8 other locations) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | April 2026 |
| Study ends | July 2026 |
| Registry record updated | December 3, 2025 |
| Trial ID | NCT07093450 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult patients admitted to one of the participating Brazilian ICUs during the intervention period.
✕Probably not a fit
Patients under 18 and adults cared for outside the participating ICUs will not be covered by the intervention and are unlikely to benefit directly.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SAFE-REDUCE is a hybrid effectiveness-implementation stepped-wedge cluster randomized trial that sequentially introduces an educational quality-improvement intervention to 10 adult ICUs participating in the IMPACTO-MR registry. The intervention combines training for ICU and infection-control teams with ongoing audit-and-feedback based on current antimicrobial and microbiology guidelines. Investigators will use routine IMPACTO-MR data to compare antimicrobial consumption during control and intervention phases and monitor safety outcomes including ICU mortality and length of stay. All adult patients admitted to participating ICUs are included in analyses, with patients under 18 excluded from individual-level analyses.
Why it matters
Potential benefit: If successful, the intervention could lower unnecessary antibiotic use in ICUs, reducing drug exposure, side effects, and selection pressure for resistant organisms.
How similar studies have gone: Antimicrobial stewardship programs using audit-and-feedback have reduced antibiotic use in hospitals elsewhere, though large randomized stepped-wedge ICU trials are relatively uncommon.
Who can join: the full rules
Show full inclusion / exclusion criteria
Intensive care units inclusion Criteria: * ICU leadership acceptance to participant in the quality improvement intervention; * Hospital infection control leadership acceptance to participant in the quality improvement intervention; * ICU participation in the IMPACTO-MR platform with high quality data; * ICU potential for quality improvement based on a subjective assessment of the ICU and hospital infection leaderships Intensive care units exclusion Criteria: \- Absence of local IRB approval Participants inclusion Criteria: * All patients admitted to the intensive care unit Participants exclusion Criteria: * Patients younger than 18 years-old will be excluded from individual-level analysis
Where it's running
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Hospital Maternidade São José
Colatina, Espírito Santo, Brazil Recruiting -
Santa Casa de Misericórdia de Passos
Passos, Minas Gerais, Brazil Recruiting -
Hospital Municipal de Maringá
Maringá, Paraná, Brazil Recruiting -
Hospital Pelópidas Silveira
Recife, Pernambuco, Brazil Recruiting -
Hospital Naval Marcílio Dias
Rio de Janeiro, Rio de Janeiro, Brazil Recruiting -
Hospital Onofre Lopes
Natal, Rio Grande do Norte, Brazil Recruiting
Show 3 more locations
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Hospital de Pronto Socorro
Porto Alegre, Rio Grande do Sul, Brazil Recruiting -
Hospital Santa Cruz
Santa Cruz do Sul, Rio Grande do Sul, Brazil Recruiting -
Santa Casa de Misericórdia de Barretos
Barretos, São Paulo, Brazil Recruiting
Study contacts
- Principal investigator: Bruno A M P Besen, M.D., Ph.D. — Hospital Sirio-Libanes
- Study coordinator: Camila Dietrich
- Email: camila.dietrich@hsl.org.br
- Phone: +55 51 9723-2844
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.