Clinical Trial

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

Study acronym: SAFE-REDUCE
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated December 3, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to learn if an educational intervention with audit and feedback on physicians and health care professionals who participate in antimicrobial treatment decisions can reduce the use of antimicrobials in adult patients admitted to a sample of Brazilian intensive care units (ICUs). The educational intervention is based on a literature review of current recommendations for a more rational use of antimicrobials and microbiological tests in daily ICU practice. The main questions it aims to answer are: * Does the educational intervention reduce the antimicrobial consumption in the intensive care units? * Does this educational intervention aiming to reduce antimicrobial utilization in accordance with the latest guidelines have any safety signals regarding ICU mortality rates or ICU length-of-stay? Researchers will compare (1) ICUs sequentially randomized to this quality improvement educational intervention aimed at improving antimicrobial utilization to (2) the same ICUs at months where the educational intervention has not been delivered yet. Each participant ICU will transition to the quality improvement intervention approximately each month, starting at July, 2025. This quality improvement intervention is based on current recommendations for antimicrobial stewardship from regulatory agencies and medical societies, including cognitive aids for physicians to improve decision-making regarding the commencement of antimicrobials, their duration and antimicrobial time-outs. The investigators hypothesize that intensivists (ICU doctors) need to embrace antimicrobial stewardship as a core competence of their daily activities.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-22.
Trial Details
NCT Number NCT07093450
Lead Sponsor Hospital Sirio-Libanes
Collaborators: Hospital do Coracao, Hospital Israelita Albert Einstein, Beneficência Portuguesa de São Paulo
Conditions Infection, Antimicrobial Stewardship, Critically Ill Intensive Care Unit Patients
Enrollment 9,000 participants
Start Date 2025-06-01
Primary Completion 2026-04 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-12-03