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.
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
Severe immunocompromise/immunosuppression
Congenital immunodeficiency
HIV with CD4 < 20
Active chemotherapy and profound neutropenia (ANC < 100) expected to last > 7 days;
Parallel
Biomarker-signature supported antibiotic treatment recommendation
Diagnostic testThe 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
Diagnostic testAntibiotic treatment decision will be based on clinical assessment only (BV test result remains masked)
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.
All cause mortality
Death from any cause during the follow-up period.
Days of antibiotic therapy (DOT)
Total number of days each participant received systemic antibacterial therapy during the study period.
Antibiotic-free days
Number of days alive and not receiving systemic antibiotic therapy during the follow-up period.
Adverse events
Number of participants experiencing treatment-related adverse events during the follow-up period, including serious adverse events.
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).
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McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
