<p>BuruliRIFDACC Study Protocol.</p>

High-dose rifampicin could shorten treatment and improve outcomes. We evaluated whether a 4-week high-dose regimen could improve time to clearance of viable <i>Mycobacterium ulcerans</i>.</p> <p>Methodology</p><p>In this open-label, individually randomised trial conducted in Ghana, participants with PCR-confirmed BU were assigned (1:1) to either high-dose oral rifampicin (20mg/kg) with clarithromycin (15mg/kg) for 4 weeks (HR) or standard-dose rifampicin (10mg/kg) with clarithromycin (15mg/kg) for 8 weeks (SR).

All wounds were dressed with DACC-coated dressings. The primary outcome was time to clearance of viable <i>M. ulcerans</i> assessed by 16S rRNA qPCR up to week 20.</p> <p>Findings</p><p>Between 26^th November 2021 and 31^st July 2024, 42 participants were randomised (HR:23, SR:19), which was short of the target (n = 112). The mean time to clearance was 4.9 weeks (SE 1.4) in the HR arm versus 7.0 weeks (SE 1.9) in the SR arm, with an adjusted mean difference of -0.5 weeks (95%CI -5.0 to 4.1, p = 0.835).