Actively Recruiting
Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-03-19
1200
Participants Needed
4
Research Sites
168 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted to the Intensive Care Unit (ICU)
- Started on antibiotics for any suspected or confirmed infection within the past 72 hours
- Treating doctor(s) willing to consider BV test result in antibiotic treatment decision making
You will not qualify if you...
- Severe immunocompromise or immunosuppression including:
- Congenital immunodeficiency
- HIV with CD4 count less than 20
- Active chemotherapy with profound neutropenia (ANC less than 100) expected to last more than 7 days
- Solid organ or stem cell transplant within the past 6 months with active graft-versus-host disease
- Receiving high dose steroids (prednisone over 20mg/day for 2 weeks or more)
- Advanced metastatic cancer regardless of treatment
- Palliative intent with death expected within 4 weeks
- Antibiotic treatment planned to be stopped within 24 hours (such as prophylaxis)
- Active infection treated with antibiotics within the past 2 weeks
- Previously included in the study during the same hospital stay
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Actively Recruiting
2
Research Institute of McGill University Health Center (RI-MUHC)
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
3
Royal Victoria Hospital
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
4
Research Institute McGill University Health Centre
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
Research Team
M
Makeda Semret, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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