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Can a simple blood test help ICU doctors use antibiotics wisely?

NCT ID NCT07481773

Knowledge-focused Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a biomarker signature (BV score) can help doctors decide when to use antibiotics for ICU patients. About 1,200 adults in intensive care who started antibiotics within the past 72 hours will be randomly assigned to have their treatment guided by the biomarker plus clinical judgment, or by clinical judgment alone. The goal is to see if the biomarker approach leads to better patient outcomes and less unnecessary antibiotic use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Biomarker-signature supported antibiotic treatment recommendation (diagnostic test)
What this could lead to
If successful, this could help doctors make better antibiotic decisions in ICUs, reducing side effects and antibiotic resistance while improving patient outcomes.
What could go wrong
This is an early-stage study focused on decision-making, not a new drug. The biomarker may not reliably distinguish bacterial from non-bacterial infections, and results may not apply to all ICU patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intensive care unit (ICU) admission

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Montreal General Hospital

    RECRUITING

    Montreal, Quebec, H3G 1A4, Canada

  • Research Institute McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A3J1, Canada

  • Research Institute of McGill University Health Center (RI-MUHC)

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Royal Victoria Hospital

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

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