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 Apr 22, 2020
Phillips RO, Robert J, Abass KM, et al. - Fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) was compared with oral rifampicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8; standard antimicrobial treatment) in terms of efficacy and tolerability when used for treatment of early Buruli ulcer lesions. Researchers conducted an open-label, non-inferiority, randomized (1:1 with blocks of six), multicenter, phase 3 clinical trial including 297 patients with PCR-confirmed Buruli ulcer. RS8 treatment was provided to 151 (51%), and oral RC8 treatment was provided to 146 (49%) patients. In the RS8 group and the RC8 group, lesions healed in 144 of 151 patients vs 140 of 146 patients, respectively. 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, they support using this regimen as the preferred therapy for early, limited lesions of Buruli ulcer.
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