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<p>BuruliRIFDACC Study Protocol.</p>
Abigail Agbanyo (16035202)
Yaw Ampem Amoako (9910077)
Charles Opondo (225509)
Michael Ntiamoah Oppong (10906266)
Adwoa Asante-Poku (335717)
Jacob Novignon (4104145)
Joseph Tuffour (25138422)
Ishaque Saim Mintah (25138425)
Ruth Dede Tuwor (16035199)
Dzifa Kofi Ahiatrogah (22453281)
Richard Adjei Akuffo (17054527)
Miriam Gborglah (20355414)
Iris Mosweu (662442)
Catherine Pitt (124328)
Elizabeth Allen (59854)
Stephen L. Walker (7879070)
Dorothy Yeboah-Manu (120059)
Michael Marks (276442)
Richard Odame Phillips (6906821)
Medicine
Microbiology
Cell Biology
Pharmacology
Immunology
Cancer
Infectious Diseases
Virology
secondary infection rates
nominally lower proportion
b >,</ b
16s rrna qpcr
mycobacterium ulcerans </
trial registration number
treat buruli ulcer
significantly shorter time
th </ sup
st </ sup
dose rifampicin combination
dose oral rifampicin
adjusted mean difference
hr arm vs
ghana </ p
ulcerans </
buruli ulcer
dose rifampicin
mean time
either arm
14534 </
well tolerated
week regimen
sr arm
recurrences occurred
primary outcome
paradoxical reactions
pactr202011867644311 (<
november 2021
larger trials
july 2024
individually randomized
improve outcomes
healing compared
find evidence
evaluated whether
determine efficacy
current 8
controlled trial
coated dressings
835 ).
8 weeks
112 ).
102 ).
<div>
<p>Background</p><p>The current 8-week regimen of rifampicin and clarithromycin for Buruli ulcer (BU) is suboptimal. 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<sup>th</sup> November 2021 and 31<sup>st</sup> 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). No recurrences occurred in either arm. Paradoxical reactions were observed in 0/21 participants in the HR arm vs. 5/15 in the SR arm (adjusted OR 0.19, 95%CI 0.00-1.35, p = 0.102). Secondary infection rates were similar between groups.</p>
<p>Conclusion</p><p>High‑dose rifampicin combination for 4 weeks was well tolerated in this population. A nominally lower proportion of paradoxical reactions was observed in the high-dose rifampicin arm compared with standard therapy. The trial did not find evidence of significantly shorter time to microbiological clearance or healing compared with standard therapy. Larger trials are needed to determine efficacy and safety.</p>
<p>Trial Registration</p><p>Pan African Clinical Trials Repository<b>,</b> trial registration number: PACTR202011867644311 (<a href="https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14534" target="_blank">https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14534</a>).</p></div>
2026-09-29T18:02:08Z
Text
Journal contribution
10.1371/journal.pntd.0014783.s001
https://figshare.com/articles/journal_contribution/_p_BuruliRIFDACC_Study_Protocol_p_/34026795
CC BY 4.0