Biomarker-guided antibiotic decisions for ICU patients
Official title: Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT07481773 · Data updated 2026-11-12
This trial will test whether using a biomarker signature to guide antibiotic decisions for ICU patients who recently started antibiotics can reduce unnecessary antibiotic use without causing worse outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1200 (estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Montreal, Quebec and 3 other locations) |
| Status | Recruiting |
| Started | May 13, 2025 |
| Main results expected | May 2028 |
| Study ends | August 2028 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT07481773 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are ICU patients who started antibiotics within the past 72 hours and whose treating clinicians are willing to consider the BV test result when making antibiotic decisions.
✕Probably not a fit
Patients with severe immunosuppression, advanced metastatic cancer, those receiving high-dose steroids or recent transplant with active GVHD, imminently dying patients, or those whose antibiotics are to be stopped within 24 hours are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, pragmatic trial assigns eligible ICU patients 1:1 to either a biomarker-signature (BV) supported antibiotic recommendation plus clinical assessment or to usual clinical assessment alone. The intervention pairs a diagnostic BV result with a treatment decision matrix intended to mimic real-life, best-case antibiotic stewardship. The primary combined endpoint is a safety-and-efficacy evaluation at 28 days using DOOR combined with RADAR to capture clinical outcomes and antibiotic exposure. The goal is to lower antibiotic duration/exposure while monitoring for any increase in infection-related harms or adverse events.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary antibiotic use in ICU patients while preserving patient safety.
How similar studies have gone: Previous biomarker-guided antibiotic strategies (for example procalcitonin-guided algorithms) have shown reductions in antibiotic use in some trials, but this specific BV signature and decision-matrix combination is newer and less widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted to the Intensive Care Unit (ICU) * Started on antibiotics for any suspected or confirmed infection in the preceding 72 hours (about 3 days) * Treating doctor(s) willing to consider BV test result in antibiotic treatment decision making Exclusion Criteria: * Severe immunocompromise/immunosuppression 1. Congenital immunodeficiency 2. HIV with CD4 \< 20 3. Active chemotherapy and profound neutropenia (ANC \< 100) expected to last \> 7 days; 4. solid organ or stem cell transplant within preceding 6 months AND active GVHD 5. Receiving high dose steroids (Pred \> 20mg/day for \> or = 2 weeks) * Advanced metastatic cancer irrespective of treatment * Palliative intent, death imminent and inevitable within 4 weeks * Antibiotic to be discontinued within 24h (ex. Prophylaxis) * Active infection diagnosed and treated with antibiotics within preceding 2 weeks * Previously included during the same hospitalization
Where it's running
-
Montreal General Hospital
Montreal, Quebec, Canada Recruiting -
Research Institute of McGill University Health Center (RI-MUHC)
Montreal, Quebec, Canada Recruiting -
Royal Victoria Hospital
Montreal, Quebec, Canada Recruiting -
Research Institute McGill University Health Centre
Montreal, Quebec, Canada Recruiting
Study contacts
- Study coordinator: Makeda Semret, MD
- Email: makeda.semret@mcgill.ca
- Phone: 15149341934
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.