A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design

dc.creatorPenna, Gerson Oliveira
dc.creatorPontes, Maria Araci de Andrade
dc.creatorCruz, Rossilene
dc.creatorGonçalves, Heitor de Sá
dc.creatorPenna, Maria Lucia Fernandes
dc.creatorBührer-Sékula, Samira
dc.date2020-05-21T13:56:21Z
dc.date2020-05-21T13:56:21Z
dc.date2012
dc.date.accessioned2023-09-26T23:49:23Z
dc.date.available2023-09-26T23:49:23Z
dc.identifierPENNA, Gerson Oliveira et al. A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 107, p. 22-27, dec. 2012. Supl. 1.
dc.identifier0074-0276
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/41339
dc.identifier10.1590/s0074-02762012000900005
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8894595
dc.descriptionGerson Oliveira Penna - Fundação Oswaldo Cruz. Fiocruz Brasília. Brasília, DF, Brasil. Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta à informação no documento.
dc.descriptionLeprosy will continue to be a public health problem for several decades. The World Health Organization (WHO) recommends that, for treatment purposes, leprosy cases be classified as either paucibacillary or multibacillary (MB). A uniform leprosy treatment regimen would simplify treatment and halve the treatment duration for MB patients. The clinical trial for uniform multidrug therapy (U-MDT) for leprosy patients (LPs) in Brazil is a randomised, open-label clinical trial to evaluate if the effectiveness of U-MDT for leprosy equals the regular regimen, to determine the acceptability of the U-MDT regimen and to identify the prognostic factors. This paper details the clinical trial methodology and patient enrolment data. The study enrolled 858 patients at two centres and 78.4% of participants were classified as MB according to the WHO criteria. The main difficulty in evaluating a new leprosy treatment regimen is that no reliable data are available for the current treatment regimen. Relapse, reaction and impaired nerve function rates have never been systematically determined, although reaction and impaired nerve function are the two major causes of nerve damage that lead to impairments and disabilities in LPs. Our study was designed to overcome the need for reliable data about the current treatment and to compare its efficacy with that of a uniform regimen.
dc.formatapplication/pdf
dc.formatapplication/pdf
dc.languageeng
dc.publisherInstituto Oswaldo Cruz
dc.rightsopen access
dc.subjectDrug Therapy, Combination
dc.subjectLeprostatic Agents
dc.subjectLeprosy, Multibacillary
dc.subjectLeprosy, Paucibacillary
dc.subjectTreatment Outcome
dc.subjectClinical Protocols
dc.subjectLeprosy
dc.subjectProtocol
dc.subjectClinical trial
dc.subjectUniform multidrug therapy
dc.subjectHanseníase
dc.subjectQuimioterapia Combinada
dc.subjectHansenostáticos
dc.subjectResultado do Tratamento
dc.subjectProtocolos Clínicos
dc.subjectDoenças Transmissíveis
dc.titleA clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design
dc.typeArticle


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