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| ID | Type | Description | Link |
|---|---|---|---|
| FRN 194227 | Other Grant/Funding Number | Canadian Institutes of Health Research (CIHR) |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
This study will pragmatically combine the evaluation of a diagnostic test with an antibiotic treatment decision matrix, in a manner that mimics real-life but is as close as possible to a "best-case" scenario.
Primary objective is to evaluate the combined endpoint of efficacy and safety at 28 days (approximately 4 weeks). This will include:
Eligible participants will be randomized 1:1 to either the intervention or control groups. Evaluation of safety and efficacy will be combined to provide a global evaluation of the benefits and risks of the intervention, using the Desirability of Outcome Ranking (DOOR) further combined with Response Adjusted for Duration of Antibiotic Risk (RADAR).
The hypothesis is that participants in the intervention group will have lower antibiotic exposure, without increased harm (worse clinical outcomes related to infection or significant adverse events) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinically-Supported Antibiotic Treatment Recommendation | Active Comparator | Participants in the control group will have antibiotic treatment recommendations based on clinical assessment alone. The BV-signature test result will remain hidden. |
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| Combined clinical and BV-supported antibiotic treatment recommendation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker-signature supported antibiotic treatment recommendation | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Death from any cause during the follow-up period. | 28 +/- 2 days |
| Days of antibiotic therapy (DOT) | Total number of days each participant received systemic antibacterial therapy during the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of drug-resistant organisms. | To assess the incidence of colonization or infection with drug-resistant organisms (Carbapenem-resistant Gram-negative bacilli, Vancomycin-Resistant Enteroocci VRE, Methicillin-Resistant S. aureus MRSA, C. difficile). | 28 days+/- 2 |
Inclusion Criteria:
Exclusion Criteria:
Severe immunocompromise/immunosuppression
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Makeda Semret, MD | Contact | 15149341934 | 35081 | makeda.semret@mcgill.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital | Recruiting | Montreal | Quebec | H3G 1A4 | Canada |
Probably will be shared, but will need to review with funders and sponsors.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Clinical study protocol v1.6 | Sep 3, 2025 |
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Pivotal Study, Observer-Blind, Randomized Control Trial
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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.
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| Clinical assessment for antibiotic treatment decision | Diagnostic Test | Antibiotic treatment decision will be based on clinical assessment only (BV test result remains masked) |
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| 28 +/- 2 days |
| Antibiotic-free days | Number of days alive and not receiving systemic antibiotic therapy during the follow-up period. | 28 days+/- 2 |
| Adverse events | Number of participants experiencing treatment-related adverse events during the follow-up period, including serious adverse events. | 28 +/- 2 days |
| Length of stay in the Intensive Care Unit | Duration of stay in the intensive care unit, measured in days from ICU admission to ICU discharge. | 28 +/- 2 days |
| Research Institute of McGill University Health Center (RI-MUHC) | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| Royal Victoria Hospital | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| Research Institute McGill University Health Centre | Recruiting | Montreal | Quebec | H4A3J1 | Canada |
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| Feb 24, 2026 |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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