Comparing Clinical assessment for antibiotic with Biomarker-signature supported for intensive care unit (ICU) admission
Official title: Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU
Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units
- 2 groups
- 4 sites in Montreal
- Recruiting
Interventions
- Other intervention
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.
- Other intervention
Clinical assessment for antibiotic treatment decision
Antibiotic treatment decision will be based on clinical assessment only (BV test result remains masked)
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
Montreal General Hospital
Montreal, Quebec
- Recruiting
Research Institute of McGill University Health Center (RI-MUHC)
Montreal, Quebec
- Recruiting
Royal Victoria Hospital
Montreal, Quebec
- Recruiting
Research Institute McGill University Health Centre
Montreal, Quebec
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- −HIV with CD4 \< 20
- −Severe immunocompromise/immunosuppression
- −Congenital immunodeficiency
- −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
- −Active chemotherapy and profound neutropenia (ANC \< 100) expected to last \> 7 days;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Clinical assessment for antibiotic treatment decision.
Registry label: A: Clinically-Supported Antibiotic Treatment Recommendation
Group B receives one or more of: BiomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more →-signature supported antibiotic treatment recommendation and Clinical assessment for antibiotic treatment decision.
Registry label: B: Combined clinical and BV-supported antibiotic treatment recommendation
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,200 people.
The study is currently expected to finish around August 2028.
The main measurement is taken over: 28 days+/- 2.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Desirability of Outcome Ranking Adjusted for Antibiotic Risk (DOOR-RADAR) — measured over 28 days+/- 2.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07481773 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.
Read the full explanation → · in clinical review
About Clinical assessment for antibiotic treatment decisionDiagnostic test
Antibiotic treatment decision will be based on clinical assessment only (BV test result remains masked)
From the trial registry — its own words, unedited.
What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 28 days+/- 2.
The study as a whole is currently expected to finish around 2028-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,200 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.