Rifampicin (10 mg/kg once daily) and clarithromycin (7.5 mg/kg twice daily) are the two oral WHO recommended antibiotics used to treatment Buruli ulcer patients for 8 weeks. This project is a phase III clinical trial that seeks to demonstrate the non-inferiority of a Beta-Lactam containing regimen, Amoxicillin/Clavulate, for shortening Buruli ulcer treatment. The Amoxicillin/Clavulanate is a suitable antibiotics for both children and adults and has high bactericidal activity. Amoxicillin/Clavulate has shown synergitic properties with rifampicin and clarithromycin against Mycobacterium ulcerans. The amoxicillin/clavulanate plus Rifampicin and clarithromycin is expected to improve healing and shortening BU therapy.
- To assess whether BU treatment could be reduced from 8 weeks to 4 weeks by co-administration of amoxicillin/clavulanate with current rifampicin-clarithromycin therapy.
- To assess the effectiveness of amoxicillin/clavulanate plus rifampicin and clarithromycin to and shorten BU therapy
- To assess the safety of this combination therapy
The study has been designed as a single blinded, randomised, controlled open label non-inferiority phase III, multicentre multi-country clinical trial. Participants of this study will be stratified according to BU category lesions and be randomized into two oral regimens;
- Standard [RC8]: rifampicin plus clarithromycin (RC) therapy for 8 weeks
- Investigational [RCA4]: standard (RC) plus amoxicillin/clavulanate (A) for 4 weeks.
There are two sites from Ghana (Nkawie-Toase Government Hospital & St. Peter’s Catholic Hospital-Jacobu), one site from Togo and Cote d’Ivoire.
The primary outcome of the study will be the complete lesion healing and the cure rate, i.e. lesion healing without recurrence and excision surgery after 12 months after initial treatment. This study is expected to provide evidence for the WHO for new policy generation and new BU standard treatment. This clinical trial may also provide relevant information for shortening treatment for other mycobacterium infections.