Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU

Recruiting now · Not applicable

Conditions studied: Intensive Care Unit (ICU) Admission

In brief

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.

Key facts

Study ID

NCT07481773

Run by

McGill University Health Centre/Research Institute of the McGill University Health Centre

People needed

1200

Starts

2025-05-13

Expected to finish

2028-08-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Montreal General Hospital — Montreal, Quebec, Canada (enrolling)
• Research Institute of McGill University Health Center (RI-MUHC) — Montreal, Quebec, Canada (enrolling)
• Royal Victoria Hospital — Montreal, Quebec, Canada (enrolling)
• Research Institute McGill University Health Centre — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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