Intensive Care Unit (ICU) AdmissionBAST-ICUNCT07481773
Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU
A study testing Biomarker-signature supported antibiotic treatment recommendation and Clinical assessment for antibiotic treatment decision in people with Intensive Care Unit (ICU) Admission, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit (ICU) Admission
- What is being tested?
- Biomarker-signature supported antibiotic treatment recommendation and Clinical assessment for antibiotic treatment decision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 4 sitesCanada
- Study dates
- 13 May 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Makeda Semret, MD, FRCP(C), makeda.semret@mcgill.ca
- Recruiting
Research Institute of McGill University Health Center (RI-MUHC)
Montreal, Quebec, H4A 3J1
MD, FRCP(C), makeda.semret@mcgill.ca
Makeda Semret, MD, FRCP(C)
- Recruiting
Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
Makeda Semret, MD, FRCP(C), makeda.semret@mcgill.ca
- Recruiting
Research Institute McGill University Health Centre
Montreal, Quebec, H4A3J1
Makeda Semret, MD, 5149341934 ext. 35081, makeda.semret@mcgill.ca
About this study
Official title: Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units
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.
Read the 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) .
- Conditions
- Intensive Care Unit (ICU) Admission
- Being tested
- Biomarker-signature supported antibiotic treatment recommendation, Clinical assessment for antibiotic treatment decision
- Keywords
- ICU, Antibiotic Assesment, Diagnostic, Intervention, Medical Device, Antimicrobial Stewardship, Antimicrobial Resistance
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker-signature supported antibiotic treatment recommendationDiagnostic test
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.
Clinical assessment for antibiotic treatment decisionDiagnostic test
Antibiotic treatment decision will be based on clinical assessment only (BV test result remains masked)
| Study group | Role | What they receive |
|---|---|---|
| Clinically-Supported Antibiotic Treatment Recommendation | Active comparator | Participants in the control group will have antibiotic treatment recommendations based on clinical assessment alone. The BV-signature test result will remain hidden. Receives: Diagnostic Test: Clinical assessment for antibiotic treatment decision |
| Combined clinical and BV-supported antibiotic treatment recommendation | Experimental | 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. Receives: Diagnostic Test: Biomarker-signature supported antibiotic treatment recommendation; Diagnostic Test: Clinical assessment for antibiotic treatment decision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days+/- 2
Secondary outcomes (5)
All cause mortality
Death from any cause during the follow-up period.
Measured: 28 +/- 2 days
Days of antibiotic therapy (DOT)
Total number of days each participant received systemic antibacterial therapy during the study period.
Measured: 28 +/- 2 days
Antibiotic-free days
Number of days alive and not receiving systemic antibiotic therapy during the follow-up period.
Measured: 28 days+/- 2
Adverse events
Number of participants experiencing treatment-related adverse events during the follow-up period, including serious adverse events.
Measured: 28 +/- 2 days
Length of stay in the Intensive Care Unit
Duration of stay in the intensive care unit, measured in days from ICU admission to ICU discharge.
Measured: 28 +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start13 May 2025
- Primary completionMay 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit (ICU) AdmissionStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pivotal Study, Observer-Blind, Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Makeda Semret, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481773
- Sponsor's protocol ID
- 2025-10747
- Other IDs
- FRN 194227, 2025
- Acronym
- BAST-ICU
- Status last verified
- May 2025
- First submitted
- 24 Feb 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Probably will be shared, but will need to review with funders and sponsors.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units
- ClinicalTrials.gov ID
- NCT07481773
- Acronym / sponsor ID
- BAST-ICU / 2025-10747
- Conditions
- Intensive Care Unit (ICU) Admission
- Keywords
- ICU, Antibiotic Assesment, Diagnostic, Intervention, Medical Device, Antimicrobial Stewardship, Antimicrobial Resistance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 13 May 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pivotal Study, Observer-Blind, Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Clinically-Supported Antibiotic Treatment Recommendation | Active comparator | Diagnostic Test: Clinical assessment for antibiotic treatment decisionParticipants in the control group will have antibiotic treatment recommendations based on clinical assessment alone. The BV-signature test result will remain hidden. |
| Combined clinical and BV-supported antibiotic treatment recommendation | Experimental | Diagnostic Test: Biomarker-signature supported antibiotic treatment recommendation, Diagnostic Test: Clinical assessment for antibiotic treatment decisionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Severe immunocompromise/immunosuppression
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker-signature supported antibiotic treatment recommendationThe 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 | Combined clinical and BV-supported antibiotic treatment recommendation |
| Clinical assessment for antibiotic treatment decisionAntibiotic treatment decision will be based on clinical assessment only (BV test result remains masked) | Diagnostic test | Clinically-Supported Antibiotic Treatment Recommendation, Combined clinical and BV-supported antibiotic treatment recommendation |
Primary outcome
Desirability of Outcome Ranking Adjusted for Antibiotic Risk (DOOR-RADAR)
Time frame: 28 days+/- 2
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided. Probably will be shared, but will need to review with funders and sponsors.
Related trials for Intensive Care Unit (ICU) Admission
Not yet recruitingObservational study
Supply Induced Demand in Intensive Care Unit: a Retrospective Trial
Intensive Care (ICU), Intensive Care Unit (ICU) Admission
Not yet recruitingObservational study
Kinetics and Prognostic Value of NeuroFilament Light in Post-cardiac Arrest: A Prospective Multicenter Study
Cardiac Arrest (CA), Intensive Care Unit (ICU) Admission
Not yet recruitingObservational study
Impact of Information and Participation on Decision Time for Tracheostomy or PEG in ICU Families
Intensive Care Unit (ICU) Admission, Tracheostomy
Recruiting
The PRE-VAIL Study
ARDS (Moderate or Severe), Prone Position
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarker-signature supported antibiotic treatment recommendation and Clinical assessment for antibiotic treatment decision in people with Intensive Care Unit (ICU) Admission, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Makeda Semret, MD (15149341934 ext. 35081, makeda.semret@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desirability of Outcome Ranking Adjusted for Antibiotic Risk (DOOR-RADAR) (time frame: 28 days+/- 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.