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New treatment option for Buruli Ulcer
Official title Telacebec (T) Treatment in Adults With Buruli Ulcer (BU). (TREAT BU)
ClinicalTrials.gov ID: NCT06481163
What this study is testing
What is Telacebec?
Telacebec is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for buruli ulcer.
Also referred to as Q203.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this interventional clinical trial is to demonstrate the complete BU lesion healing rate by 52 weeks after treatment initiation, without relapse and/or curative intent excision surgery, after 10-28 days of telacebec (T) treatment. Males and females age 18 and older will be included.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Major
- Clinical diagnosis of BU WHO categories, single or multiples: Category I- a single lesion \< 5 cm Category II - a single lesion with cross-sectional...
- 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
You likely can't join if
- Participants with the following known or suspected medical conditions/criteria:
- Any non BU related condition where participation in the study, as judged by the Investigator, could compromise the well-being of the participant or...
- History or current ascites, jaundice, myasthenia gravis, clinically significant renal dysfunction [estimated glomerular filtration rate (eGFR) \< 30...
- Compromised immune status (e.g. uncontrolled HIV-infection)
- History of previous BU in the previous 12 months (except current infection)
- Participants who fulfill both of the following criteria:
See the full eligibility criteria
- Major
- 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 ≤...
- 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
- Participants with the following known or suspected medical conditions/criteria:
- 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.
- History or current ascites, jaundice, myasthenia gravis, clinically significant renal dysfunction [estimated glomerular filtration rate (eGFR) \< 30 mls/min],
- Compromised immune status (e.g. uncontrolled HIV-infection)
- History of previous BU in the previous 12 months (except current infection)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Geelong, Victoria, Australia
- Melbourne, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geelong, Victoria, Australia; Melbourne, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.