Phillips 2014a.

Methods	Prospective observational study
Participants	Inclusion criteria: clinically + laboratory‐confirmed BU; at least 5 years of age, presented with lesions ≤ 15 cm in diameter (exclusion criteria: tuberculosis or leprosy; renal or hepatic impairment, auditory problems; under treatment with antibiotics or herbal preparations; pregnancy) Laboratory confirmation: IS2404 dry‐reagent‐based PCR Enrolled: 82 patients screened for BU; 17 not meeting clinical and or epidemiological criteria for BU, 18 large category III lesions, 1 pregnancy, 3 were below 5 years; 43 for analysis Participant characteristics: 18 males, 42%; median age 15 (range, 5 to 70) Lesion types: ulcer 20 (47%), nodules 14 (32%), plaque 9 (21%) WHO category I: 27 (63%), category II: 12 (28%), category III: 4 (9%)
Interventions	Rifampicin (10 mg/kg/d) + streptomycin (15 mg/kg/d), 2 weeks followed by rifampicin (10 mg/kg/d) + clarithromycin (7.5 mg/kg/d), 6 weeks The treatment was administered under the direct observation of village health workers. Surgery: when indicated; surgery and skin grafting was offered to participants whose lesion had enlarged during or after treatment by more than 150% of the initial size or had not healed by week 52. Follow‐up: 52 weeks
Outcomes	Healing of the Mycobacterium ulcerans lesion without recurrence within 12 months of treatment commencement (cure) Healing time Recurrence Adverse event (vestibulocochlear toxicity) Paradoxical reactions
Notes	Trial location: Ghana Enrolment dates: July 2009 to July 2010
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (Trials)	High risk	—
Allocation concealment (Trials)	High risk	—
Blinding of participants and personnel (Trials)	High risk	—
Blinding of outcome assessment (Trials)	High risk	—
Selection of participants into the study (Prospective observational studies)	Low risk	Selection not related to intervention or outcome.
Measurement of outcomes (Prospective observational studies)	Low risk	Objective outcome measures
Incomplete outcome data / missing data (All studies)	Low risk	Only 2 (5%) participants were lost to follow‐up.
Selective reporting (All studies)	Low risk	Reported all expected outcomes
Other bias	Low risk	No other bias identified.