Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU (BAST-ICU)

McGill University

Status: Enrolling

Conditions: Intensive Care Unit (ICU) Admission

Treatments: Diagnostic Test: Clinical assessment for antibiotic treatment decision; Diagnostic Test: Biomarker-signature supported antibiotic treatment recommendation

Study type: Interventional

Funder types: Other

Identifiers

NCT07481773

2025-10747

FRN 194227 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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) .

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

  1. Congenital immunodeficiency
  2. HIV with CD4 < 20
  3. Active chemotherapy and profound neutropenia (ANC < 100) expected to last > 7 days;
  4. solid organ or stem cell transplant within preceding 6 months AND active GVHD
  5. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Clinically-Supported Antibiotic Treatment Recommendation

Active Comparator group

Description:

Participants in the control group will have antibiotic treatment recommendations based on clinical assessment alone. The BV-signature test result will remain hidden.

Treatment:

Diagnostic Test: Clinical assessment for antibiotic treatment decision

Combined clinical and BV-supported antibiotic treatment recommendation

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Biomarker-signature supported antibiotic treatment recommendation

Diagnostic Test: Clinical assessment for antibiotic treatment decision