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Recruiting NCT07481773

Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU

No phase Interventional Intensive Care Unit (ICU) Admission

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biomarker-signature supported antibiotic treatment recommendation, Clinical assessment for antibiotic treatment decision.
Who it may be relevant to
Registry conditions: Intensive Care Unit (ICU) Admission. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units

Overview

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.

Detailed description

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) .

Interventions

  • Diagnostic test 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.
  • Diagnostic test Clinical assessment for antibiotic treatment decision
    Antibiotic treatment decision will be based on clinical assessment only (BV test result remains masked)

Primary outcome measures

  • Desirability of Outcome Ranking Adjusted for Antibiotic Risk (DOOR-RADAR) [Time frame: 28 days+/- 2]
Secondary outcome measures (5)
  • All cause mortality [Time frame: 28 +/- 2 days]
  • Days of antibiotic therapy (DOT) [Time frame: 28 +/- 2 days]
  • Antibiotic-free days [Time frame: 28 days+/- 2]
  • Adverse events [Time frame: 28 +/- 2 days]
  • Length of stay in the Intensive Care Unit [Time frame: 28 +/- 2 days]

Eligibility criteria

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 4 centers
  • Montreal General Hospital — Montreal
  • Research Institute of McGill University Health Center (RI-MUHC) — Montreal
  • Royal Victoria Hospital — Montreal
  • Research Institute McGill University Health Centre — Montreal

Identifiers

NCT: NCT07481773 · 2025-10747 · FRN 194227

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗