Rifampicin and clarithromycin (extended release) vs rifampicin and streptomycin for limited Buruli ulcer lesions: A randomized, open-label, non-inferiority phase 3 trial
The Lancet Mar 19, 2020
Phillips RO, Robert J, Abass KM, et al. - The efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) were compared with that of standard antimicrobial treatment with oral rifampicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) for treatment of early Buruli ulcer lesions. In this open-label, non-inferiority, randomized (1:1 with blocks of six), multicentre, phase 3 clinical trial, they included patients who were aged 5 years or older and had typical Buruli ulcer with no more than one lesion (categories I and II) no larger than 10 cm in diameter at four trial sites in hospitals in Ghana (Agogo, Tepa, Nkawie, Dunkwa) and one in Benin (Pobè). Recruitment was stopped after 310 patients. Among these patients, 297 patients had PCR-confirmed Buruli ulcer; RS8 treatment was provided to 151 (51%) patients, and oral RC8 treatment was provided to 146 (49%) patients. Outcomes suggest non-inferiority of fully oral RC8 regimen to RS8 for treatment of early, limited Buruli ulcer. Further, fewer adverse events were reported in correlation with fully oral RC8 regimen. Hence, fully oral RC8 supported as the preferred therapy for early, limited lesions of Buruli ulcer. .
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