Actively Recruiting
Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units
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
13 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
Researchers are evaluating whether using a biomarker-signature (BV) supported antibiotic treatment decision matrix can improve antibiotic use and patient outcomes for people admitted to the Intensive Care Unit (ICU). This study combines a diagnostic test with a treatment decision matrix to closely mimic real-life conditions, aiming to balance antibiotic use with patient safety. The main goal is to assess safety and effectiveness together at about 28 days, looking at antibiotic use and clinical outcomes. Participants will be randomly assigned to one of two groups. In the control group, antibiotic decisions will be made based on clinical assessment alone, with the BV test result hidden. In the intervention group, the BV test result will be shared with investigators and combined with clinical assessment using a decision matrix to guide antibiotic prescribing. The study compares these approaches to see if the biomarker-supported method reduces antibiotic exposure without causing harm. Throughout the study, participants will be monitored for outcomes such as all-cause mortality, days of antibiotic therapy, antibiotic-free days, adverse events, and ICU length of stay over about 28 days. Researchers will use a combined measure called the Desirability of Outcome Ranking Adjusted for Antibiotic Risk (DOOR-RADAR) to evaluate overall benefits and risks. The study will last until 2028, with assessments occurring around four weeks after treatment decisions.
CONDITIONS
Brief 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 in the preceding 72 hours
- Treating doctor(s) willing to consider BV test result in antibiotic treatment decision making
- Adults aged 18 years or older
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 expected to last more than 7 days
- Solid organ or stem cell transplant within the previous 6 months with active graft-versus-host disease
- Receiving high dose steroids (prednisone over 20 mg/day for 2 or more weeks)
- Advanced metastatic cancer regardless of treatment
- Palliative intent with death imminent and expected within 4 weeks
- Antibiotics planned to be discontinued within 24 hours (e.g., prophylaxis)
- Active infection treated with antibiotics within the preceding 2 weeks
- Previously included in the study during the same hospital stay
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants receive antibiotic treatment recommendations based on either clinical assessment alone or combined clinical and biomarker signature results to guide antibiotic use in the ICU.
Visits as part of routine ICU care during antibiotic treatment
Duration - Up to 4 weeks after treatment initiation
Participants are monitored for clinical outcomes, antibiotic exposure, adverse events, and length of ICU stay after treatment.
Assessments at Day 28 (+/- 2 days)
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
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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