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New antibiotic pill could heal Flesh-Eating ulcers in weeks

NCT ID NCT06481163

Disease control Sponsor: Barwon Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Updated 3 times

Summary

This study tests a new antibiotic called telacebec for Buruli ulcer, a bacterial skin infection that can cause large open sores. About 200 adults will take telacebec tablets for 14 to 28 days. Researchers will check if the ulcers heal completely within a year without needing surgery.

What this could mean

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

Active substance
Telacebec (also known as Q203), an antibiotic tablet
What this could lead to
If successful, this could provide a shorter, simpler antibiotic treatment for Buruli ulcer, reducing the need for surgery and lengthy therapy.
What could go wrong
This is a mid-stage trial with only 200 participants, so results may not apply to everyone. The treatment may not heal all lesions or could have side effects.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

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

Started

Jul 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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.

Major Inclusion Criteria: * Clinical diagnosis of BU WHO categories, single or multiples: Category I- a single lesion \< 5 cm Category II - a single lesion with cross-sectional diameter ≤ 10 cm Category III - where multiple and all lesions are ≤ 10 cm cross-sectional diameter * Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU). * Aged 18 years and older, except for those included in exclusion below. Major Exclusion Criteria: * Participants with the following known or suspected medical conditions/criteria: 1. Any non BU related condition where participation in the study, as judged by the Investigator, could compromise the well-being of the participant or prevent, limit or confound protocol specified treatment and assessments. 2. History or current ascites, jaundice, myasthenia gravis, clinically significant renal dysfunction \[estimated glomerular filtration rate (eGFR) \< 30 mls/min\], 3. Compromised immune status (e.g. uncontrolled HIV-infection) 4. History of previous BU in the previous 12 months (except current infection) 5. Participants who fulfill both of the following criteria: * Aged ≥ 60 years * Weight ≥ 85 kg * Planned/expected to require curative intent excision surgery, defined as excision of lesion which may include surrounding macroscopically healthy tissue with the aim of helping to sterilize the wound rather than improve wound healing alone, for their BU during the entire study period. Simple removal of necrotic slough and skin grafting is considered normal wound care and allowed.

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Conditions

The condition(s) this trial relates to.

Buruli ulcer disease ulcer disease

As listed by the trial registrant

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

Buruli ulcer

How to take part

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

  1. The places running it

    2 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

  • Barwon Health

    RECRUITING

    Geelong, Victoria, 3220, Australia

  • Royal Melbourne Hospital

    RECRUITING

    Melbourne, Australia

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