NCT07093450 Quality Improvement Intervention for a Safe Antimicrobial Use Reduction in Critically Ill Patients
| NCT ID | NCT07093450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Sirio-Libanes |
| Condition | Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 9,000 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 9,000 participants in total. It began in 2025-06-01 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Bruno A M P Besen, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Hospital Sirio-Libanes
Frequently Asked Questions
Who can join the NCT07093450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07093450 currently recruiting?
Yes, NCT07093450 is actively recruiting participants. Contact the research team at camila.dietrich@hsl.org.br for enrollment information.
Where is the NCT07093450 trial being conducted?
This trial is being conducted at Colatina, Brazil, Passos, Brazil, Maringá, Brazil, Recife, Brazil and 5 additional locations.
Who is sponsoring the NCT07093450 clinical trial?
NCT07093450 is sponsored by Hospital Sirio-Libanes. The principal investigator is Bruno A M P Besen, M.D., Ph.D. at Hospital Sirio-Libanes. The trial plans to enroll 9,000 participants.