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New rapid test could help ICU doctors pick the right antibiotic hours faster

NCT ID NCT07202377

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new rapid diagnostic system that can tell doctors which antibiotic will work against a blood infection in 4-6 hours, instead of the usual 18-24 hours. Researchers want to see if this faster information helps ICU doctors change to a better antibiotic sooner. The trial will include 200 adult ICU patients with Gram-negative bloodstream infections.

What this could mean

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

Active substance
SPECIFIC REVEAL® Rapid AST system (diagnostic test)
What this could lead to
If successful, this could show that faster lab results help doctors pick the right antibiotic sooner, potentially improving patient outcomes in the ICU.
What could go wrong
This is an early-stage study with only 200 patients, so results may not apply to all hospitals. The test itself is new and may not always be accurate or available.

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 200 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Nov 2026

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: * Adult patients aged over 18 years * Patients with a positive blood culture for Gram-negative bacilli (Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii) with results reported on weekdays before 11:00 ante meridiem (AM) * Patients clinically suspected of infection * Treated with empirical antibiotic therapy including a β-lactam, among the standard list of antibiotics to be tested recommended by CASFM-EUCAST (European Committee on Antimicrobial Susceptibility Testing) for Enterobacterales/Pseudomonas and included in the Reveal Rapid AST System panel * Hospitalized in intensive care unit (ICU) for at least the next 24 hours * Written informed consent obtained from the patient or a relative for study participation (emergency consent) * Affiliated with the French social security system Exclusion Criteria: * Patients receiving withdrawal or limitation of care * Patients with an expected survival prognosis of less than 72 hours * Patients with bloodstream infections caused by Gram-negative bacilli other than Acinetobacter baumannii, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa * Patients treated with antibiotic therapy not including a β-lactam * Polymicrobial bloodstream infections * Pregnant or breastfeeding women * Patients under legal protection (guardianship or conservatorship) * Participation in another interventional research study

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis gram-negative bacterial infections

As listed by the trial registrant

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

Gram-negative bacteremia Intensive care patients

How to take part

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  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.