Clinical Research Directory

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.