Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU
BAST-ICU
2 other identifiers
interventional
1,200
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2025
CompletedFirst Submitted
Initial submission to the registry
February 24, 2026
CompletedFirst Posted
Study publicly available on registry
March 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
March 19, 2026
May 1, 2025
3 years
February 24, 2026
March 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Desirability of Outcome Ranking Adjusted for Antibiotic Risk (DOOR-RADAR)
The primary outcome is the Desirability of Outcome Ranking (DOOR), which ranks each participant according to overall clinical outcome based on a hierarchical composite that incorporates mortality, infection recurrence, infection relapse and treatment-related adverse events. Participants are assigned to mutually exclusive outcome ranks (1 to 5), with 1 representing the most desirable outcome (alive, none of treatment failure/recurrence or adverse events) and 5 representing the least desirable outcome (death). Within each clinical outcome category, participants will be further ranked according to antibiotic exposure using the Response Adjusted for Duration of Antibiotic Risk (RADAR) approach, such that shorter duration of antibiotic therapy is considered more desirable. The primary analysis will estimate the probability that a randomly selected participant in the intervention group has a more desirable outcome than a participant in the comparator group.
28 days+/- 2
Secondary Outcomes (5)
All cause mortality
28 +/- 2 days
Days of antibiotic therapy (DOT)
28 +/- 2 days
Antibiotic-free days
28 days+/- 2
Adverse events
28 +/- 2 days
Length of stay in the Intensive Care Unit
28 +/- 2 days
Other Outcomes (1)
Incidence of drug-resistant organisms.
28 days+/- 2
Study Arms (2)
Clinically-Supported Antibiotic Treatment Recommendation
ACTIVE COMPARATORParticipants in the control group will have antibiotic treatment recommendations based on clinical assessment alone. The BV-signature test result will remain hidden.
Combined clinical and BV-supported antibiotic treatment recommendation
EXPERIMENTALThe 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
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.
Antibiotic treatment decision will be based on clinical assessment only (BV test result remains masked)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Research Institute of McGill University Health Center (RI-MUHC)
Montreal, Quebec, H4A 3J1, Canada
Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
Research Institute McGill University Health Centre
Montreal, Quebec, H4A3J1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- All team members and participants remain blinded during the Enrollment and Clinical Assessment Stages. The study team, (PI/CO-Is that are ID physicians, pharmacist, and laboratory technologist performing BV testing), will remain blinded while conducting the clinical assessment and laboratory testing. The results of the MeMed BV diagnostic test will only be disclosed for participants in the experimental group but not for those in the control group. The study and treating team will be informed of the treatment group assignment when the intervention begins, specifically when the clinical assessment is completed.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator (NPA)
Study Record Dates
First Submitted
February 24, 2026
First Posted
March 19, 2026
Study Start
May 13, 2025
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
March 19, 2026
Record last verified: 2025-05