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New dye test could spot Flesh-Eating bacteria in minutes

NCT ID NCT06877793

Diagnosis Sponsor: Eric R. Henderson 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a safe, FDA-approved dye called indocyanine green (ICG) can help doctors quickly tell the difference between a life-threatening flesh-eating infection (necrotizing fasciitis) and a less dangerous skin infection. About 420 adults with suspected infections will receive the dye and have special camera images taken. The goal is to see if the dye's movement through tissue reveals blocked blood vessels, a hallmark of necrotizing infections, enabling faster and more accurate diagnosis.

What this could mean

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

Active substance
indocyanine green (ICG) dye
What this could lead to
If successful, this could give doctors a fast, accurate way to diagnose necrotizing fasciitis in the emergency room, reducing delays and improving survival.
What could go wrong
This is an early-stage study testing a new use for an existing dye. It may not prove accurate enough across different hospitals or bacteria types, and false results could still occur.

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.

Participants

About 420 people

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

Started

Sep 2025

Expected to finish

Jul 2030

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.

Who is studied

Patients presenting to the ED or clinic who are considered at intermediate- or high-risk for NSTI.

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: * Age ≥18 years. * Clinical suspicion of NSTI based on the local standard of care warranting: * Hospital admission for observation due to suspected NSTI; and/or * Soft tissue biopsy to rule in/out suspected NSTI; and/or * Surgical debridement for suspected NSTI; and/or * Specific institutional threshold criteria for triggering NSTI work-up; and * Ability to give written informed consent. Exclusion Criteria: * History of allergy to ICG and/or iodine. * Pregnant women or nursing mothers.

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Conditions

The condition(s) this trial relates to.

necrotizing fasciitis necrotizing soft tissue infection

As listed by the trial registrant

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

Necrotizing fascitis

How to take part

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

  1. The places running it

    8 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

  • Dartmouth-Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Emory University/Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Stanford University

    RECRUITING

    Stanford, California, 94305, United States

  • University of California, Los Angeles

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48104, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Vanderbilt University

    RECRUITING

    Nashville, Tennessee, 37235, United States

More trials for these conditions

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