Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07093450

Quality Improvement Intervention to Reduce Antimicrobial Use in Intensive Care Units in Brazil

Led by Hospital Sirio-Libanes · Updated on 2025-12-03

9000

Participants Needed

9

Research Sites

13 weeks

Total Duration

On this page

Sponsors

H

Hospital Sirio-Libanes

Lead Sponsor

H

Hospital do Coracao

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate whether an educational quality improvement intervention focused on antimicrobial stewardship can reduce antimicrobial use in adult patients admitted to intensive care units (ICUs) in Brazil. The study compares current ICU practices with those after implementing the intervention, which is based on up-to-date guidelines and aims to promote rational antimicrobial use without increasing ICU mortality or length of stay. The trial uses a stepped-wedge cluster randomized design across 10 ICUs participating in the IMPACTO-MR registry platform. The intervention includes educational sessions, cognitive aids for ICU physicians and healthcare professionals to improve decisions on antimicrobial initiation and duration, and monthly audits with feedback to the ICU teams. Each ICU starts with a control phase of usual care, then transitions to the intervention phase approximately monthly starting July 2025. The study also includes a baseline data collection period before the intervention and a phase-out period to assess lasting effects after stopping feedback. Participants are all adult patients admitted to the participating ICUs during the study. Researchers will collect monthly one-day point-prevalence surveys on antimicrobial use and monitor ICU mortality rates and length of stay over 14 months to evaluate outcomes. The study will assess the impact of the educational intervention on antimicrobial use while ensuring patient safety, with no individual informed consent required due to cluster-level data collection and minimal risk.

CONDITIONS

Brief Title

Quality Improvement Intervention for a Safe Antimicrobial Use Reduction in Critically Ill Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ICU leadership agrees to participate in the quality improvement intervention
  • Hospital infection control leadership agrees to participate
  • ICU participates in the IMPACTO-MR platform with high quality data
  • ICU has potential for quality improvement based on leadership assessment
  • All patients admitted to participating intensive care units
  • Participants must be 18 years or older
Not Eligible

You will not qualify if you...

  • Absence of local institutional review board (IRB) approval
  • Patients younger than 18 years old are excluded from individual-level analysis

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Initial site visit for educational sessions and assessment of implementation barriers

Surveillance

Duration - 1 month

Participants in intensive care units are observed during the control phase with routine standard-of-care practices before the quality improvement intervention begins.

Monthly point-prevalence surveys on one day each month

Educational Quality Improvement Intervention

Duration - Up to 10 months

Participants receive a quality improvement intervention including educational sessions, cognitive aids for antimicrobial decision-making, and monthly audits with feedback to improve antimicrobial use.

Monthly one-day audits with immediate feedback sessions

Long-term Monitoring

Duration - 3 months

Participants are observed after the intervention phase to evaluate whether benefits in antimicrobial use are sustained without ongoing feedback.

Monthly point-prevalence surveys on one day each month

Trial Site Locations

Total: 9 locations

1

Hospital Maternidade São José

Colatina, Espírito Santo, Brazil

Actively Recruiting

2

Santa Casa de Misericórdia de Passos

Passos, Minas Gerais, Brazil

Actively Recruiting

3

Hospital Municipal de Maringá

Maringá, Paraná, Brazil

Actively Recruiting

4

Hospital Pelópidas Silveira

Recife, Pernambuco, Brazil

Actively Recruiting

5

Hospital Naval Marcílio Dias

Rio de Janeiro, Rio de Janeiro, Brazil

Actively Recruiting

6

Hospital Onofre Lopes

Natal, Rio Grande do Norte, Brazil

Actively Recruiting

7

Hospital de Pronto Socorro

Porto Alegre, Rio Grande do Sul, Brazil

Actively Recruiting

8

Hospital Santa Cruz

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Actively Recruiting

9

Santa Casa de Misericórdia de Barretos

Barretos, São Paulo, Brazil

Actively Recruiting

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Research Team

C

Camila Dietrich

B

Bruno M Tomazini

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units.

Bruno M Tomazini, Antonio Paulo Nassar, Thiago Costa Lisboa...

https://pubmed.ncbi.nlm.nih.gov/36888821