MedTrace Logo

Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU

NCT07481773 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

  • Intensive Care Unit (ICU) Admission

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)

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2028-05-31
Completion
2028-08-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07481773 on ClinicalTrials.gov