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

Detalhes bibliográficos
Autor(a) principal: Penna, Gerson Oliveira
Data de Publicação: 2012
Outros Autores: Pontes, Maria Araci de Andrade, Cruz, Rossilene, Gonçalves, Heitor de Sá, Penna, Maria Lucia Fernandes, Bührer-Sékula, Samira
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/41339
Resumo: Gerson 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.
id CRUZ_398ee5ecdd1fdd388af34ce1182b8a46
oai_identifier_str oai:www.arca.fiocruz.br:icict/41339
network_acronym_str CRUZ
network_name_str Repositório Institucional da FIOCRUZ (ARCA)
repository_id_str 2135
spelling Penna, Gerson OliveiraPontes, Maria Araci de AndradeCruz, RossileneGonçalves, Heitor de SáPenna, Maria Lucia FernandesBührer-Sékula, Samira2020-05-21T13:56:21Z2020-05-21T13:56:21Z2012PENNA, 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. 1.0074-0276https://www.arca.fiocruz.br/handle/icict/4133910.1590/s0074-02762012000900005Gerson 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.Universidade de Brasília. Faculdade de Medicina. Núcleo de Medicina Tropical. Brasília, DF, Brasil.Centro de Dermatologia Dona Libânia. Fortaleza, CE, Brasil.Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta. Manaus, AM, Brasil.Centro de Dermatologia Dona Libânia. Fortaleza, CE, Brasil.Universidade Federal Fluminense. Departamento de Epidemiologia e Bioestatística. Niterói, RJ, Brasil.Universidade Federal de Goiás. Instituto de Patologia Tropical e Saúde Pública. Goiânia, GO, Brasil.Leprosy 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.engInstituto Oswaldo CruzDrug Therapy, CombinationLeprostatic AgentsLeprosy, MultibacillaryLeprosy, PaucibacillaryTreatment OutcomeClinical ProtocolsLeprosyProtocolClinical trialUniform multidrug therapyHanseníaseQuimioterapia CombinadaHansenostáticosResultado do TratamentoProtocolos ClínicosDoenças TransmissíveisA clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and designinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/41339/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALve_Gerson_Penna_etal.pdfve_Gerson_Penna_etal.pdfArtigoapplication/pdf1983885https://www.arca.fiocruz.br/bitstream/icict/41339/2/ve_Gerson_Penna_etal.pdff0e5f9eb41500ed549bc638862ce3d8fMD52ve_Gerson_Penna_etal_anexo.pdfve_Gerson_Penna_etal_anexo.pdfAnexoapplication/pdf1446310https://www.arca.fiocruz.br/bitstream/icict/41339/3/ve_Gerson_Penna_etal_anexo.pdf6e03a576992fa024a24950c232afbd6dMD53TEXTve_Gerson_Penna_etal.pdf.txtve_Gerson_Penna_etal.pdf.txtExtracted texttext/plain350480https://www.arca.fiocruz.br/bitstream/icict/41339/4/ve_Gerson_Penna_etal.pdf.txt318babd9189ccb3f3b5e54329004791fMD54ve_Gerson_Penna_etal_anexo.pdf.txtve_Gerson_Penna_etal_anexo.pdf.txtExtracted texttext/plain321881https://www.arca.fiocruz.br/bitstream/icict/41339/5/ve_Gerson_Penna_etal_anexo.pdf.txtdd533ae72b257f958b7476834dfcf11eMD55icict/413392020-06-16 11:49:28.793oai:www.arca.fiocruz.br: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ório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352020-06-16T14:49:28Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.pt_BR.fl_str_mv A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design
title A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design
spellingShingle A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design
Penna, Gerson Oliveira
Drug Therapy, Combination
Leprostatic Agents
Leprosy, Multibacillary
Leprosy, Paucibacillary
Treatment Outcome
Clinical Protocols
Leprosy
Protocol
Clinical trial
Uniform multidrug therapy
Hanseníase
Quimioterapia Combinada
Hansenostáticos
Resultado do Tratamento
Protocolos Clínicos
Doenças Transmissíveis
title_short A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design
title_full A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design
title_fullStr A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design
title_full_unstemmed A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design
title_sort A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design
author Penna, Gerson Oliveira
author_facet Penna, Gerson Oliveira
Pontes, Maria Araci de Andrade
Cruz, Rossilene
Gonçalves, Heitor de Sá
Penna, Maria Lucia Fernandes
Bührer-Sékula, Samira
author_role author
author2 Pontes, Maria Araci de Andrade
Cruz, Rossilene
Gonçalves, Heitor de Sá
Penna, Maria Lucia Fernandes
Bührer-Sékula, Samira
author2_role author
author
author
author
author
dc.contributor.author.fl_str_mv Penna, Gerson Oliveira
Pontes, Maria Araci de Andrade
Cruz, Rossilene
Gonçalves, Heitor de Sá
Penna, Maria Lucia Fernandes
Bührer-Sékula, Samira
dc.subject.mesh.pt_BR.fl_str_mv Drug Therapy, Combination
Leprostatic Agents
Leprosy, Multibacillary
Leprosy, Paucibacillary
Treatment Outcome
Clinical Protocols
topic Drug Therapy, Combination
Leprostatic Agents
Leprosy, Multibacillary
Leprosy, Paucibacillary
Treatment Outcome
Clinical Protocols
Leprosy
Protocol
Clinical trial
Uniform multidrug therapy
Hanseníase
Quimioterapia Combinada
Hansenostáticos
Resultado do Tratamento
Protocolos Clínicos
Doenças Transmissíveis
dc.subject.en.pt_BR.fl_str_mv Leprosy
Protocol
Clinical trial
Uniform multidrug therapy
dc.subject.decs.pt_BR.fl_str_mv Hanseníase
Quimioterapia Combinada
Hansenostáticos
Resultado do Tratamento
Protocolos Clínicos
Doenças Transmissíveis
description Gerson 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.
publishDate 2012
dc.date.issued.fl_str_mv 2012
dc.date.accessioned.fl_str_mv 2020-05-21T13:56:21Z
dc.date.available.fl_str_mv 2020-05-21T13:56:21Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv PENNA, 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.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/41339
dc.identifier.issn.pt_BR.fl_str_mv 0074-0276
dc.identifier.doi.none.fl_str_mv 10.1590/s0074-02762012000900005
identifier_str_mv PENNA, 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.
0074-0276
10.1590/s0074-02762012000900005
url https://www.arca.fiocruz.br/handle/icict/41339
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Instituto Oswaldo Cruz
publisher.none.fl_str_mv Instituto Oswaldo Cruz
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/41339/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/41339/2/ve_Gerson_Penna_etal.pdf
https://www.arca.fiocruz.br/bitstream/icict/41339/3/ve_Gerson_Penna_etal_anexo.pdf
https://www.arca.fiocruz.br/bitstream/icict/41339/4/ve_Gerson_Penna_etal.pdf.txt
https://www.arca.fiocruz.br/bitstream/icict/41339/5/ve_Gerson_Penna_etal_anexo.pdf.txt
bitstream.checksum.fl_str_mv 5a560609d32a3863062d77ff32785d58
f0e5f9eb41500ed549bc638862ce3d8f
6e03a576992fa024a24950c232afbd6d
318babd9189ccb3f3b5e54329004791f
dd533ae72b257f958b7476834dfcf11e
bitstream.checksumAlgorithm.fl_str_mv MD5
MD5
MD5
MD5
MD5
repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
_version_ 1798325054310711296