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

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Randomised trial to compare clarithromycin (extended release)rifampicin and streptomycin-rifampicin for early, limited lesions of M. ulcerans infection.pdf(3.12 MB)
Date
2019-10-01
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The Lancet
Abstract
Background 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%.
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An article published by The Lancet
Keywords
Buruli ulcer, Mycobacterium ulcerans, drug treatment, randomized clinical trial
Citation
The Lancet, SSRN: https://ssrn.com/abstract=3458507
URI
https://ir.knust.edu.gh/handle/123456789/11952
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