Actively Recruiting
Telacebec (T) Treatment in Adults With Buruli Ulcer (BU).
Led by Barwon Health · Updated on 2025-12-10
140
Participants Needed
2
Research Sites
125 weeks
Total Duration
On this page
Sponsors
B
Barwon Health
Lead Sponsor
G
Global Alliance for TB Drug Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this interventional clinical trial is to determine if treatment with 2-4 weeks of telacebac (T) will completely heal lesions in participants with Buruli ulcer (BU) by 52 weeks after treatment initiation, without relapse and/or surgery. Males and females age 18 and older will be included. • Participants will attend visits every 2 weeks during treatment and thereafter every 2 weeks until week 24 Thereafter they will be followed by visits at weeks 30, 40, and 52. From week 10 to week 52, if the lesion has healed, follow-up visits may be remote.
CONDITIONS
Official Title
Telacebec (T) Treatment in Adults With Buruli Ulcer (BU).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Buruli ulcer
- Positive PCR or culture confirming Mycobacterium ulcerans infection
- Age 18 years or older
You will not qualify if you...
- Any non-Buruli ulcer medical condition that could affect safety or study assessments as judged by the Investigator
- History or current ascites, jaundice, myasthenia gravis, or significant kidney dysfunction (eGFR < 30 mls/min)
- History of Buruli ulcer within the past 12 months (except current infection)
- Planned or expected need for curative excision surgery for Buruli ulcer during the study period (simple removal of necrotic tissue and skin grafting allowed)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Barwon Health
Geelong, Victoria, Australia, 3220
Actively Recruiting
2
Royal Melbourne Hospital
Melbourne, Australia
Actively Recruiting
Research Team
B
Bree Sarah
CONTACT
K
Kate Ellis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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