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A 5-hour test may replace days of waiting for the right antibiotic in blood infections

NCT ID NCT06174649

Diagnosis Sponsor: Duke University 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests whether a rapid diagnostic test called Reveal can improve outcomes for hospitalized patients with gram-negative bloodstream infections. The test measures bacterial growth by detecting gases they release, giving results in about 5 hours instead of the usual 2-3 days. Patients are randomly assigned to receive either standard testing or the rapid test plus standard care, and researchers track survival, complications, and recovery up to 30 days.

What this could mean

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

Active substance
a rapid diagnostic test called Reveal that measures bacterial growth by detecting volatile metabolites
What this could lead to
If successful, this rapid test could help doctors choose the right antibiotic hours sooner, potentially reducing complications and deaths from bloodstream infections.
What could go wrong
The test may not work as well in all settings or for all bacteria, and faster results do not guarantee better outcomes. The trial is still testing this question.

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

899 people

The number who actually took part.

Started

Dec 2023

Finished

Jun 2025

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Positive blood culture with Gram stain showing GNB. 2. Hospitalized at the time of Gram stain result. 3. Enrolled within 16 hours of blood culture positivity. Exclusion Criteria: 1. Positive blood culture for GNB within the prior 7 days (if known at the time of Gram stain result). 2. Deceased at the time of Gram stain result. 3. Gram-positive bacilli, Gram-positive cocci, Gram-negative cocci, yeast, fungi, or multiple morphologies of GNB detected on Gram stain of blood culture. 4. Previous enrollment in this study.

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis gram-negative bacterial infections Sepsis

As listed by the trial registrant

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

Bloodstream infection Gram-negative bacteremia

Contacts and locations

Locations

  • Attikon University General Hospital

    Chaïdári, Attica, 12462, Greece

  • Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas

    A Coruña, 15006, Spain

  • Kasturba Medical College, Mangalore

    Attāvara, Mangalore, 575001, India

  • Meir Medical Center

    Kfar Saba, 4428162, Israel

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Tzaneio General Hospital

    Piraeus, 18536, Greece

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