{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T18:51:07Z","timestamp":1791399067689,"version":"4.3.3"},"update-to":[{"DOI":"10.1371\/journal.pntd.0014783","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T00:00:00Z","timestamp":1791331200000}}],"reference-count":33,"publisher":"Public Library of Science (PLoS)","issue":"9","license":[{"start":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T00:00:00Z","timestamp":1790640000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","award":["NIHR200125"],"award-info":[{"award-number":["NIHR200125"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National Institute of Health and Care Research","award":["NIHR200125"],"award-info":[{"award-number":["NIHR200125"]}]},{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","award":["NIHR304258"],"award-info":[{"award-number":["NIHR304258"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosntds.org"],"crossmark-restriction":false},"short-container-title":["PLoS Negl Trop Dis"],"abstract":"\n Background<\/jats:title>\n \n 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\n Mycobacterium ulcerans<\/jats:italic>\n .\n <\/jats:p>\n <\/jats:sec>\n \n Methodology<\/jats:title>\n \n 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\n M. ulcerans<\/jats:italic>\n assessed by 16S rRNA qPCR up to week 20.\n <\/jats:p>\n <\/jats:sec>\n \n Findings<\/jats:title>\n \n Between 26\n th<\/jats:sup>\n November 2021 and 31\n st<\/jats:sup>\n July 2024, 42 participants were randomised (HR:23, SR:19), which was short of the target (n\u2009=\u2009112). 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\u2009=\u20090.835). 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\u2009=\u20090.102). Secondary infection rates were similar between groups.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n High\u2011dose 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.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n Pan African Clinical Trials Repository\n ,<\/jats:bold>\n trial registration number: PACTR202011867644311 (\n https:\/\/pactr.samrc.ac.za\/TrialDisplay.aspx?TrialID=14534<\/jats:ext-link>\n ).\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1371\/journal.pntd.0014783","type":"journal-article","created":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T17:37:21Z","timestamp":1790703441000},"page":"e0014783","update-policy":"https:\/\/doi.org\/10.1371\/journal.pntd.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["High-dose rifampicin and clarithromycin for 4 weeks versus standard-dose rifampicin and clarithromycin for 8 weeks to treat Buruli ulcer: An open-label, individually randomized, controlled trial in Ghana"],"prefix":"10.1371","volume":"20","author":[{"given":"Abigail","family":"Agbanyo","sequence":"first","affiliation":[{"name":"Centre for Collaborative Research, Kwame Nkrumah University of Science and Technology","place":["Kumasi, Ghana"]},{"name":"School of Medical Sciences, Kwame Nkrumah University of Science and Technology","place":["Kumasi, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4642-789X","authenticated-orcid":true,"given":"Yaw Ampem","family":"Amoako","sequence":"additional","affiliation":[{"name":"Centre for Collaborative Research, Kwame Nkrumah University of Science and Technology","place":["Kumasi, Ghana"]},{"name":"School of Medical Sciences, Kwame Nkrumah University of Science and Technology","place":["Kumasi, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8155-4117","authenticated-orcid":true,"given":"Charles","family":"Opondo","sequence":"additional","affiliation":[{"name":"London School of Hygiene and Tropical Medicine","place":["London, United Kingdom"],"department":["Department of Medical Statistics and the Clinical Trials Unit, Faculty of Epidemiology and Population Health"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael Ntiamoah","family":"Oppong","sequence":"additional","affiliation":[{"name":"Centre for Collaborative Research, Kwame Nkrumah University of Science and Technology","place":["Kumasi, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adwoa","family":"Asante-Poku","sequence":"additional","affiliation":[{"name":"Noguchi Memorial Institute for Medical Research, University of Ghana","place":["Accra, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4718-9328","authenticated-orcid":true,"given":"Jacob","family":"Novignon","sequence":"additional","affiliation":[{"name":"Centre for Social Policy Studies, University of Ghana","place":["Accra, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Tuffour","sequence":"additional","affiliation":[{"name":"Noguchi Memorial Institute for Medical Research, University of Ghana","place":["Accra, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ishaque Saim","family":"Mintah","sequence":"additional","affiliation":[{"name":"Noguchi Memorial Institute for Medical Research, University of Ghana","place":["Accra, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-8864-7520","authenticated-orcid":true,"given":"Ruth Dede","family":"Tuwor","sequence":"additional","affiliation":[{"name":"Centre for Collaborative Research, Kwame Nkrumah University of Science and Technology","place":["Kumasi, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dzifa Kofi","family":"Ahiatrogah","sequence":"additional","affiliation":[{"name":"Centre for Collaborative Research, Kwame Nkrumah University of Science and Technology","place":["Kumasi, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard Adjei","family":"Akuffo","sequence":"additional","affiliation":[{"name":"Noguchi Memorial Institute for Medical Research, University of Ghana","place":["Accra, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-2708-0842","authenticated-orcid":true,"given":"Miriam","family":"Gborglah","sequence":"additional","affiliation":[{"name":"Centre for Collaborative Research, Kwame Nkrumah University of Science and Technology","place":["Kumasi, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris","family":"Mosweu","sequence":"additional","affiliation":[{"name":"London School of Hygiene and Tropical Medicine","place":["London, United Kingdom"],"department":["Department of Global Health and Development, Faculty of Public Health and Policy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Pitt","sequence":"additional","affiliation":[{"name":"London School of Hygiene and Tropical Medicine","place":["London, United Kingdom"],"department":["Department of Global Health and Development, Faculty of Public Health and Policy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Allen","sequence":"additional","affiliation":[{"name":"London School of Hygiene and Tropical Medicine","place":["London, United Kingdom"],"department":["Department of Medical Statistics and the Clinical Trials Unit, Faculty of Epidemiology and Population Health"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2034-8376","authenticated-orcid":true,"given":"Stephen L.","family":"Walker","sequence":"additional","affiliation":[{"name":"London School of Hygiene and Tropical Medicine","place":["London, United Kingdom"],"department":["Department of Clinical Research, Faculty of Infectious and Tropical Diseases"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dorothy","family":"Yeboah-Manu","sequence":"additional","affiliation":[{"name":"Noguchi Memorial Institute for Medical Research, University of Ghana","place":["Accra, Ghana"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Marks","sequence":"additional","affiliation":[{"name":"London School of Hygiene and Tropical Medicine","place":["London, United Kingdom"],"department":["Department of Clinical Research, Faculty of Infectious and Tropical Diseases"]},{"name":"Hospital for 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