Safer antibiotic use in adult intensive care units

Estudo de Implementação de Melhoria de Qualidade Para Redução do Uso de Antimicrobianos em Unidades de Terapia Intensiva

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

• Phase: NA
• Study type: Interventional
• Enrollment: 9000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Sirio-Libanes (other)
• Locations: 9 sites (Colatina, Espírito Santo and 8 other locations)
• Trial ID: NCT07093450 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adult patients admitted to one of the participating Brazilian ICUs during the intervention period.

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.

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 performed: Antimicrobial stewardship programs using audit-and-feedback have reduced antibiotic use in hospitals elsewhere, though large randomized stepped-wedge ICU trials are relatively uncommon.

Eligibility 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 this trial is running

Colatina, Espírito Santo and 8 other locations

• 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)
• 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

Conditions: Infection, Antimicrobial Stewardship, Critically Ill Intensive Care Unit Patients, Antimicrobial stewardship, Intensive care unit, Stepped-wedge cluster trials, Hybrid effectiveness-implementation trials, Diagnostic stewardship