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: * Efficacy: Assessed by the use of antibiotics. * Safety: Assessed by clinical outcomes. 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) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
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)
Montreal General Hospital
Montreal, Quebec, Canada
RECRUITINGResearch Institute of McGill University Health Center (RI-MUHC)
Montreal, Quebec, Canada
RECRUITINGRoyal Victoria Hospital
Montreal, Quebec, Canada
RECRUITINGDesirability 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.
Time frame: 28 days+/- 2
All cause mortality
Death from any cause during the follow-up period.
Time frame: 28 +/- 2 days
Days of antibiotic therapy (DOT)
Total number of days each participant received systemic antibacterial therapy during the study period.
Time frame: 28 +/- 2 days
Antibiotic-free days
Number of days alive and not receiving systemic antibiotic therapy during the follow-up period.
Time frame: 28 days+/- 2
Adverse events
Number of participants experiencing treatment-related adverse events during the follow-up period, including serious adverse events.
Time frame: 28 +/- 2 days
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Research Institute McGill University Health Centre
Montreal, Quebec, Canada
RECRUITINGLength of stay in the Intensive Care Unit
Duration of stay in the intensive care unit, measured in days from ICU admission to ICU discharge.
Time frame: 28 +/- 2 days