Clinical trial Recruiting at 9 sites Interventional Ages 18 and up

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.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment9000 (estimated)
SponsorHospital Sirio-Libanes
Academic / other
Locations9 sites (Colatina, Espírito Santo and 8 other locations)
StatusRecruiting
StartedJune 1, 2025
Main results expectedApril 2026
Study endsJuly 2026
Registry record updatedDecember 3, 2025
Trial IDNCT07093450 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.