Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU
Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units
McGill University Health Centre/Research Institute of the McGill University Health Centre
1,200 participants
May 13, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria11
- Severe immunocompromise/immunosuppression
- Congenital immunodeficiency
- HIV with CD4 \< 20
- Active chemotherapy and profound neutropenia (ANC \< 100) expected to last \> 7 days;
- solid organ or stem cell transplant within preceding 6 months AND active GVHD
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Antibiotic treatment decision will be based on clinical assessment only (BV test result remains masked)
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07481773