NCT07481773

Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU

Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized clinical trial is to determine whether a biomarker-signature (BV) supported antibiotic treatment decision matrix can have a beneficial impact on antibiotic use and patient outcomes in an ICU population.

Detailed description

This study will pragmatically combine the evaluation of a diagnostic test with an antibiotic treatment decision matrix, in a manner that mimics real-life but is as close as possible to a "best-case" scenario. Primary objective is to evaluate the combined endpoint of efficacy and safety at 28 days (approximately 4 weeks). This will include: * Efficacy: Assessed by the use of antibiotics. * Safety: Assessed by clinical outcomes. Eligible participants will be randomized 1:1 to either the intervention or control groups. Evaluation of safety and efficacy will be combined to provide a global evaluation of the benefits and risks of the intervention, using the Desirability of Outcome Ranking (DOOR) further combined with Response Adjusted for Duration of Antibiotic Risk (RADAR). The hypothesis is that participants in the intervention group will have lower antibiotic exposure, without increased harm (worse clinical outcomes related to infection or significant adverse events) .

Conditions

• Intensive Care Unit (ICU) Admission

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Biomarker-signature supported antibiotic treatment recommendation	The antibiotic treatment recommendation will be based on a decision matrix that combines the results of the BV-signature (a score ranging from 0 -100) with the clinical assessment of likelihood of bacterial infection.
DIAGNOSTIC_TEST	Clinical assessment for antibiotic treatment decision	Antibiotic treatment decision will be based on clinical assessment only (BV test result remains masked)

Timeline

• Start date: 2025-05-13
• Primary completion: 2028-05-01
• Completion: 2028-08-01
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

4 sites across 1 country: Canada