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Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU

RecruitingNAAges 18 Years - anyAllMcGill University Health Centre/Research Institut…
NCT07481773 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Biomarker-signature supported antibiotic treatment recommendation
  • Clinical assessment for antibiotic treatment decision
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Where

4 sites
Montreal General Hospital
Montreal, Canada
Research Institute of McGill University Health Center (RI-MUHC)
Montreal, Canada
Royal Victoria Hospital
Montreal, Canada
Research Institute McGill University Health Centre
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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