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Table · dataset · 2026

<p>Characteristics of participants at recruitment.</p>

Listed in ZivaHub and HKU DataHub and DaYta Ya Rona and figshare and Loughborough Research Repository and UP Research Data Repository — shown once because both records carry DOI 10.1371/journal.pntd.0014783.t001

<div> <p>Background</p><p>The current 8-week regimen of rifampicin and clarithromycin for Buruli ulcer (BU) is suboptimal.

Description

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).

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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, trial registration number: PACTR202011867644311 (<a href="pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14534" target="_blank">pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14534</a>).</p></div>

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Catalogue records · 1

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Provenance · 6 source records, 82 field assertions
SourceKeyLast seenRaw
ZivaHuboai:figshare.com:article/3402680710 d agoJSON v1
HKU DataHuboai:figshare.com:article/3402680710 d agoJSON v1
DaYta Ya Ronaoai:figshare.com:article/3402680710 d agoJSON v1
figshareoai:figshare.com:article/340268079 d agoJSON v1
Loughborough Research Repositoryoai:figshare.com:article/340268079 d agoJSON v1
UP Research Data Repositoryoai:figshare.com:article/340268079 d agoJSON v1
FieldAssertionExtractorEvidence
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concepts[disease].local:disease:cancermapping · zivahub uct ac zavocabulary-mapper@1.0.0keywords['Cancer']
concepts[disease].local:disease:cancermapping · dayta nwu ac zavocabulary-mapper@1.0.0keywords['Cancer']
concepts[disease].local:disease:cancermapping · figshare comvocabulary-mapper@1.0.0keywords['Cancer']
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concepts[field].anzsrc:field:310706mapping · dayta nwu ac zavocabulary-mapper@1.0.0keywords['Virology']
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concepts[field].anzsrc:group:3107mapping · dayta nwu ac zavocabulary-mapper@1.0.0keywords['Microbiology']
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concepts[field].local:field:earth-environmentalmapping · zivahub uct ac zaconnector:zivahub_uct_ac_za@1.0.0
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concepts[field].local:field:economics-financemapping · figshare comconnector:figshare_com@1.0.0
concepts[field].local:field:economics-financemapping · repository lboro ac ukconnector:repository_lboro_ac_uk@1.0.0
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concepts[field].local:field:medicine-healthmapping · zivahub uct ac zaconnector:zivahub_uct_ac_za@1.0.0
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concepts[field].local:field:medicine-healthmapping · datahub hku hkconnector:datahub_hku_hk@1.0.0
concepts[field].local:field:medicine-healthmapping · dayta nwu ac zaconnector:dayta_nwu_ac_za@1.0.0
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concepts[field].local:field:social-sciencemapping · dayta nwu ac zaconnector:dayta_nwu_ac_za@1.0.0
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concepts[field].local:field:social-sciencemapping · figshare comconnector:figshare_com@1.0.0
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