A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil

Detalhes bibliográficos
Autor(a) principal: Machado, Paulo Roberto Lima
Data de Publicação: 2020
Outros Autores: Prates, Fernanda V. O., Boaventura, Viviane, Lago, Tainã, Guimarães, Luiz Henrique, Schriefer, Albert, Corte, Temis W. F., Penna, Gerson Oliveira, Barral, Aldina Maria do Prado, Barral-Netto, Manoel, Carvalho, Edgar Marcelino
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
DOI: 10.1093/cid/ciaa1337
Texto Completo: https://www.arca.fiocruz.br/handle/icict/45507
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.
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spelling Machado, Paulo Roberto LimaPrates, Fernanda V. O.Boaventura, VivianeLago, TainãGuimarães, Luiz HenriqueSchriefer, AlbertCorte, Temis W. F.Penna, Gerson OliveiraBarral, Aldina Maria do PradoBarral-Netto, ManoelCarvalho, Edgar Marcelino2021-01-05T14:26:42Z2021-01-05T14:26:42Z2020MACHADO, Paulo R. L. et al. A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil. Clinical Infectious Disease, [s.l], n. ciaa1337, p. 1-5, set. 2020.1058-4838https://www.arca.fiocruz.br/handle/icict/4550710.1093/cid/ciaa1337Gerson 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.Fundação Oswaldo Cruz (Fiocruz) e Ministério da Saúde (MS)Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, Brasil / Ministério da Ciência, Tecnologia, Inovações e Comunicações. Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais. Brasília, DF, Brasil.Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, Brasil / Ministério da Ciência, Tecnologia, Inovações e Comunicações. Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais. Brasília, DF, Brasil.Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, Brasil.Universidade Federal do Sul da Bahia. Teixeira de Freitas, BA, Brasil.Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, Brasil / Ministério da Ciência, Tecnologia, Inovações e Comunicações. Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais. Brasília, DF, Brasil.Quatro G Pesquisa & Desenvolvimento. Porto Alegre, RS, Brasil.Universidade de Brasília. Faculdade de Medicina Tropical. Núcleo de Medicina Tropical. Brasília, DF, Brasil.Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, Brasil / Ministério da Ciência, Tecnologia, Inovações e Comunicações. Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais. Brasília, DF, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.Background: The treatment of cutaneous leishmaniasis (CL) in Brazil using pentavalent antimony (Sbv) is associated with a high rate of failure. Miltefosine has proven efficacy for CL caused by L. braziliensis, with a cure rate (CR) of 75%. A combined treatment with granulocyte macrophage colony-stimulating factor (GM-CSF) and miltefosine could increase CR and decrease healing time. Methods: A randomized, double-blind clinical trial to evaluate the efficacy of miltefosine combined with topical GM-CSF (M +GM) vs miltefosine and placebo (M + P) vs Sbv in 133 patients with CL caused by L. braziliensis in Bahia, Brazil. Results: The final CR at 180 days after the initiation of treatment was 44.4% in the Sbv group, 76.6% in the M + P group (P = .003 vs Sbv), and 75.6% in the M + GM group (P = .004 vs Sbv). The median healing time for cure was 102 days for the Sbv group and 60 days for both miltefosine groups (P = .0009). During the 6-month follow-up period, 4 relapses were documented: 1 in the Sbv group, 1 in the M + P group, and 2 in the M + GM group. Mild adverse events occurred in 65% of patients from the Sbv group, 76% and 79% from the M + P and M + GM groups respectively. Conclusions: Miltefosine is more effective than Sbv for the treatment of CL caused by L. braziliensis in Brazil and accelerates the healing time. Association with GM-CSF does not improve therapeutic outcome.engOxford University Presshttps://www.arca.fiocruz.br/handle/icict/44288Leishmaniasis, CutaneousLeishmania braziliensisCutaneous leishmaniasisMiltefosineGM-CSFPentavalent antimonyLeishmania (V.) braziliensisLeishmanioseLeishmaniose CutâneaResultado do TratamentoLeishmania braziliensisA double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazilinfo: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; 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dc.title.pt_BR.fl_str_mv A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil
title A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil
spellingShingle A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil
Machado, Paulo Roberto Lima
Leishmaniasis, Cutaneous
Leishmania braziliensis
Cutaneous leishmaniasis
Miltefosine
GM-CSF
Pentavalent antimony
Leishmania (V.) braziliensis
Leishmaniose
Leishmaniose Cutânea
Resultado do Tratamento
Leishmania braziliensis
title_short A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil
title_full A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil
title_fullStr A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil
title_full_unstemmed A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil
title_sort A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil
author Machado, Paulo Roberto Lima
author_facet Machado, Paulo Roberto Lima
Prates, Fernanda V. O.
Boaventura, Viviane
Lago, Tainã
Guimarães, Luiz Henrique
Schriefer, Albert
Corte, Temis W. F.
Penna, Gerson Oliveira
Barral, Aldina Maria do Prado
Barral-Netto, Manoel
Carvalho, Edgar Marcelino
author_role author
author2 Prates, Fernanda V. O.
Boaventura, Viviane
Lago, Tainã
Guimarães, Luiz Henrique
Schriefer, Albert
Corte, Temis W. F.
Penna, Gerson Oliveira
Barral, Aldina Maria do Prado
Barral-Netto, Manoel
Carvalho, Edgar Marcelino
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Machado, Paulo Roberto Lima
Prates, Fernanda V. O.
Boaventura, Viviane
Lago, Tainã
Guimarães, Luiz Henrique
Schriefer, Albert
Corte, Temis W. F.
Penna, Gerson Oliveira
Barral, Aldina Maria do Prado
Barral-Netto, Manoel
Carvalho, Edgar Marcelino
dc.subject.mesh.pt_BR.fl_str_mv Leishmaniasis, Cutaneous
Leishmania braziliensis
topic Leishmaniasis, Cutaneous
Leishmania braziliensis
Cutaneous leishmaniasis
Miltefosine
GM-CSF
Pentavalent antimony
Leishmania (V.) braziliensis
Leishmaniose
Leishmaniose Cutânea
Resultado do Tratamento
Leishmania braziliensis
dc.subject.en.pt_BR.fl_str_mv Cutaneous leishmaniasis
Miltefosine
GM-CSF
Pentavalent antimony
Leishmania (V.) braziliensis
dc.subject.decs.pt_BR.fl_str_mv Leishmaniose
Leishmaniose Cutânea
Resultado do Tratamento
Leishmania braziliensis
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 2020
dc.date.issued.fl_str_mv 2020
dc.date.accessioned.fl_str_mv 2021-01-05T14:26:42Z
dc.date.available.fl_str_mv 2021-01-05T14:26:42Z
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 MACHADO, Paulo R. L. et al. A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil. Clinical Infectious Disease, [s.l], n. ciaa1337, p. 1-5, set. 2020.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/45507
dc.identifier.issn.pt_BR.fl_str_mv 1058-4838
dc.identifier.doi.none.fl_str_mv 10.1093/cid/ciaa1337
identifier_str_mv MACHADO, Paulo R. L. et al. A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil. Clinical Infectious Disease, [s.l], n. ciaa1337, p. 1-5, set. 2020.
1058-4838
10.1093/cid/ciaa1337
url https://www.arca.fiocruz.br/handle/icict/45507
dc.language.iso.fl_str_mv eng
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dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
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dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
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