Randomised trial to compare clarithromycin (extended release)- rifampicin and streptomycin-rifampicin for early, limited lesions of M. ulcerans infection

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dc.contributor.authorPhillips, Richard Odame
dc.contributor.authorRobert, Jerome
dc.contributor.authorAbass, K. Mohamed
dc.contributor.authorThompson, William
dc.contributor.authorSarfo, Fred Stephen
dc.contributor.authoret. al
dc.date.accessioned2020-01-17T11:38:01Z
dc.date.accessioned2023-04-19T01:50:43Z
dc.date.available2020-01-17T11:38:01Z
dc.date.available2023-04-19T01:50:43Z
dc.date.issued2019-10-01
dc.descriptionAn article published by The Lanceten_US
dc.description.abstractBackground Buruli ulcer (Mycobacterium ulcerans infection) is a Neglected Tropical Disease characterised by severe subcutaneous necrosis, with occasional bone involvement. Being reported from 33 countries, it is most prevalent in West and Central Africa, and Australia. In Africa, the major burden is borne by poor rural children. If left untreated, Buruli ulcer may progress to cause severe suffering and ultimately stigmatising disability resulting in school drop-out and loss of income. Standard antimicrobial treatment with oral rifampicin 10 mg/kg and intramuscular streptomycin 15 mg/kg for eight weeks (RS8) is highly effective but streptomycin injections are painful and may cause hearing loss. Methods Between January 2013 and December 2017, we conducted an open label randomised multicentre phase III clinical trial with noninferiority design comparing fully oral treatment with rifampicin and clarithromycin 15 mg/kg extended release (RC8) with RS8. A sample size of 332 participants was calculated to detect inferiority of CR8 by a margin of 12%.en_US
dc.description.sponsorshipKNUSTen_US
dc.identifier.citationThe Lancet, SSRN: https://ssrn.com/abstract=3458507en_US
dc.identifier.urihttps://ir.knust.edu.gh/handle/123456789/11952
dc.language.isoenen_US
dc.publisherThe Lanceten_US
dc.subjectBuruli ulceren_US
dc.subjectMycobacterium ulceransen_US
dc.subjectdrug treatmenten_US
dc.subjectrandomized clinical trialen_US
dc.titleRandomised trial to compare clarithromycin (extended release)- rifampicin and streptomycin-rifampicin for early, limited lesions of M. ulcerans infectionen_US
dc.typeArticleen_US
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