Recruiting

Biomarker-Signature

Sponsor:

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

Code:

NCT07481773

Conditions

Intensive Care Unit (ICU) Admission

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biomarker-signature supported antibiotic treatment recommendation

Clinical assessment for antibiotic treatment decision

Study Details

Brief 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.

Conditions

Intensive Care Unit (ICU) Admission

Study ID

NCT07481773

Start date

May 13, 2025

Status verified date

May, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Clinically-Supported Antibiotic Treatment Recommendation

Participants in the control group will have antibiotic treatment recommendations based on clinical assessment alone. The BV-signature test result will remain hidden.

experimental: Combined clinical and BV-supported antibiotic treatment recommendation

The result of the BV test will be unmasked for the investigators and combined with the clinical assessment of the antibiotic prescription, using a decision matrix. The recommendation will be shared with the treating team.

Interventions

Biomarker-signature supported antibiotic treatment recommendation

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.

Clinical assessment for antibiotic treatment decision

Antibiotic treatment decision will be based on clinical assessment only (BV test result remains masked)

Primary outcome measure

  • Desirability of Outcome Ranking Adjusted for Antibiotic Risk (DOOR-RADAR) [ Time Frame: 28 days+/- 2 ]

Central Contacts and Locations

Central contacts

Makeda Semret, MD

15149341934makeda.semret@mcgill.ca

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Makeda Semret, MD, FRCP(C)

makeda.semret@mcgill.ca

Research Institute of McGill University Health Center (RI-MUHC)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

MD, FRCP(C)

makeda.semret@mcgill.ca

Principal Investigator:

Makeda Semret, MD, FRCP(C)

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Makeda Semret, MD, FRCP(C)

makeda.semret@mcgill.ca

Research Institute McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A3J1

Contacts

Makeda Semret, MD

5149341934makeda.semret@mcgill.ca

More Information

Sponsor

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

Last update posted

Mar 19, 2026

Last verified

May, 2025

Keywords

  • ICU, Antibiotic Assesment, Diagnostic, Intervention, Medical Device
  • Antimicrobial Stewardship
  • Antimicrobial Resistance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-03-19.