telacebec (t) treatment in adults with buruli ulcer (bu).

Conditions: Buruli Ulcer

Summary: the goal of this interventional clinical trial is to determine if treatment with 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 week during treatment (4 weeks) * thereafter they will be followed every 2 weeks until week 24 followed by visits as weeks 30, 40 and 52. * dependent on site requirements, there may be follow up visits on site or remotely.

this is an open label single arm (telacebec), multi-centre, clinical trial. eligible participants with clinically diagnosed world health organization (who) category i lesions and category ii lesions ≤10 cm cross-sectional diameter and category iii lesions where multiple and all lesions are ≤10 cm cross-sectional diameter, confirmed by polymerase chain reaction (pcr) or culture for presence of mycobacterium ulcerans infection, will receive telacebec 300 mg orally once daily for 28 days with food. participants who meet entry criteria and give consent will attend a baseline enrolment visit (day 1), then visits every week for 4 weeks during treatment (weeks 1, 2, 3 and 4). thereafter they will be followed up every 2 weeks until week 24, followed by visits at weeks 30, 40, and 52. bu lesion management will be provided to all trial participants. in case of participant early withdrawal from the trial during or after the treatment period, participants will be treated per the investigational site and/or country bu treatment guidelines. a data review committee (drc) will be established to review efficacy and safety data. enrolment and enrolled participants will continue the study whilst the drc reviews are ongoing.

Eligibility criteria:
major inclusion criteria: * clinical diagnosis of bu who categories, single or multiples: 1. i 2. ii with a cross-sectional diameter \< 10 cm 3. iii category iii lesions where multiple and all are \< 10 cm cross-sectional diameter * positive pcr or culture for confirmation of presence of mycobacterium ulcerans (mu). major exclusion criteria: * participants with the following known or suspected medical conditions: 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 \[estimated glomerular filtration rate (egfr) \ 10%\], and severe immune compromise (e.g., immunosuppressive drugs after organ transplant) 3. history of previous bu (except current infection) * 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.

Keywords: lesion ulcer