Biomarker-guided antibiotic decisions for ICU patients

Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• 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)
• Trial ID: NCT07481773 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Montreal, Quebec and 3 other locations

• 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

Conditions Intensive Care Unit Admission; ICU, Antibiotic Assesment, Diagnostic, Intervention, Medical Device; Antimicrobial Stewardship; Antimicrobial Resistance