Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07481773

Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU

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

168 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

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.

CONDITIONS

Official Title

Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted to the Intensive Care Unit (ICU)
  • Started on antibiotics for any suspected or confirmed infection within the past 72 hours
  • Treating doctor(s) willing to consider BV test result in antibiotic treatment decision making
Not Eligible

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 (ANC less than 100) expected to last more than 7 days
    • Solid organ or stem cell transplant within the past 6 months with active graft-versus-host disease
    • Receiving high dose steroids (prednisone over 20mg/day for 2 weeks or more)
  • Advanced metastatic cancer regardless of treatment
  • Palliative intent with death expected within 4 weeks
  • Antibiotic treatment planned to be stopped within 24 hours (such as prophylaxis)
  • Active infection treated with antibiotics within the past 2 weeks
  • Previously included in the study during the same hospital stay

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

M

Makeda Semret, MD

CONTACT

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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