Project Summary
Buruli ulcer is an ulcerating skin disease caused by Mycobacterium ulcerans infection that is common in tropical areas of West Africa, predominantly affecting children in the 5 to 15 year age group. Recent evidence that antibiotics are effective has shifted the balance between surgery and antibiotics. We compared the clinical and microbiological response to standard rifampicin/streptomycin for 8 weeks (RS8) with rifampicin/streptomycin for 2 weeks followed by rifampicin/clarithromycin for 6 weeks (RS2RC6) in patients with small Buruli lesions.
Eighty-three patients with confirmed Buruli ulcer were randomized to RS8 or RS2RC6 and monitored for recurrence free healing. Bacterial load in tissue samples before and after treatment for 6 and 12 weeks was monitored in samples obtained by 4mm punch biopsy by semi-quantitative culture. There was no difference in using RS8 compared with RS2RC6 with respect to healing rate or the proportion healed in each group after 4, 8, 12, 16, 20, 24 and up to 52 weeks. The success rate was 93% in each group and there was no recurrence after 12 month follow-up. There was no difference in the number of bacteria cultured at the different time points for the two regimen.
The findings from this pilot study indicate that rifampicin combined with clarithromycin can replace rifampicin and streptomycin for the continuation phase after rifampicin streptomycin for 2 weeks without any apparent loss of efficacy with the implication that a controlled trial of fully oral therapy using rifampicin and clarithromycin for 8 weeks (RC8) is justified.
