BURULICO Study 2010.

Methods	Randomized controlled trial
Participants	Inclusion criteria: clinically + laboratory‐confirmed BU; aged 5 years or older, had a reported disease duration of less than 6 months, and had lesions with a cross‐sectional diameter (indurated area) of 10 cm or less (exclusions: pregnancy, drug intolerance, and renal, hepatic, and acoustic impairment) Laboratory confirmation: IS2404 dry‐reagent‐based PCR Enrolled: 151 participants; 143 with infection confirmed by PCR, 5 with infection confirmed by other methods, 3 cases were clinical diagnosis Participant characteristics: intervention group 19 (25%) males, median 12 years (IQR 9 to 22); control group 27 (36%) males, median 12 years (IQR 8 to 18) Lesion types: ulcer 59 (39.1%), non‐ulcer 92 (60.9%) WHO category I: 58 (38.4%), category II + III: 93 (61.16%)
Interventions	Rifampicin (10 mg/kg/day) + streptomycin (15 mg/kg/day), 4 weeks followed by rifampicin (10 mg/kg/day) + clarithromycin (7.5 mg/kg/day), 4 weeks Rifampicin (10 mg/kg/day) + streptomycin (15 mg/kg/day), 8 weeks Surgery: when indicated Follow‐up: once a week participants were given study drugs to take to the nearest health facility to receive directly observed treatment for the subsequent days, with daily wound care. Participants with complicated lesions were hospitalized. Participants were followed up at weekly intervals during the first 8 weeks; at week 10, week 12, and then monthly to week 36, and bimonthly to week 52. Study visits included clinical assessment with reporting of adverse effects, measurement of lesion size (if not healed) by tracing onto an acetate sheet, and photography of the lesion.
Outcomes	Healed without surgery or recurrence (cure) Cumulative proportion of healing Difference in healing time between the 2 groups Skin grafts Recurrence Functional impairment Adverse effects (ototoxicity, nephrotoxicity, abdominal discomfort) during treatment Long‐term adverse effects (ototoxicity, nephrotoxicity) (Klis 2014)
Notes	Trial location: Ghana Enrolment dates: April 2006 to January 2008 HIV antibody testing was done with cold‐stored sera after completion of the study, in which 3 (2%) participants were found positive.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (Trials)	Low risk	Computer‐generated minimization
Allocation concealment (Trials)	Low risk	Assigned allocation was sent from a central site by text message to study co‐ordinator.
Blinding of participants and personnel (Trials)	Low risk	Open‐label, but outcome unlikely to be affected by participant knowledge of treatment group.
Blinding of outcome assessment (Trials)	Low risk	Open‐label, but primary endpoint also assessed by blinded wound experts, and the results concurred with those from the primary analysis.
Selection of participants into the study (Prospective observational studies)	Unclear risk	—
Measurement of outcomes (Prospective observational studies)	Unclear risk	—
Incomplete outcome data / missing data (All studies)	Low risk	4 participants withdrew/died/were lost to follow‐up but were still included in analysis for primary endpoint as the lesion had healed at the last assessment.
Selective reporting (All studies)	Low risk	Reported all expected outcomes
Other bias	Low risk	3 cases not laboratory‐confirmed, but only a small number.