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 (Preprint)

Machado, Paulo Roberto Lima; Prates, Fernanda V. O.; Boaventura, Viviane; Lago, Tainã; Guimarães, Luiz H.; Schriefer, Albert; Corte, Temis W. F.; Penna, Gerson Oliveira; Barral, Aldina Maria Prado; Barral Netto, Manoel; Carvalho, Edgar Marcelino

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 (Preprint)

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 H., Schriefer, Albert, Corte, Temis W. F., Penna, Gerson Oliveira, Barral, Aldina Maria Prado, Barral Netto, Manoel, Carvalho, Edgar Marcelino
Tipo de documento:	Artigo
Idioma:	eng
Título da fonte:	Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo:	https://www.arca.fiocruz.br/handle/icict/44288
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 a informação no documento.

Metadados do item

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network_acronym_str	CRUZ
network_name_str	Repositório Institucional da FIOCRUZ (ARCA)
repository_id_str	2135
spelling	Machado, Paulo Roberto LimaPrates, Fernanda V. O.Boaventura, VivianeLago, TainãGuimarães, Luiz H.Schriefer, AlbertCorte, Temis W. F.Penna, Gerson OliveiraBarral, Aldina Maria PradoBarral Netto, ManoelCarvalho, Edgar Marcelino2020-10-31T11:40:22Z2020-10-31T11:40:22Z2020MACHADO, Paulo Roberto Lima 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, p. 1-19, 2020.1058-4838https://www.arca.fiocruz.br/handle/icict/4428810.1093/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 a informação no documento.FIOCRUZ and the Ministry of Health from Brazil.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, BrasilUniversidade 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. 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.The treatment of cutaneous leishmaniasis (CL) in Brazil by pentavalent antimony (Sbv) is associated with a high rate of failure. Oral miltefosine in monotherapy has proven high efficacy in CL caused by L. braziliensis with a cure rate of 75%. A combined treatment with GM-CSF and miltefosine was tested to increase the cure rate and decrease the healing time. Methods: This is a randomized and double-blind clinical trial to evaluate the efficacy of miltefosine combined with topical GM-CSF (M+GM) versus miltefosine and placebo (M+P) versus standard Sbv in the treatment of 133 patients with CL caused by L. braziliensis in Bahia, Brazil. Results: The final cure rate at 180 days after the initiation of treatment was 44.4% in the Sbv group, 76.6% in the M+P group (P= 0.003 versus Sbv), and 75.6% in the M+GM group (P= 0.004 versus Sbv). By survival curve analysis median healing time for cure was 102 for Sbv group and 60 days for both miltefosine groups (P= 0.0009). During the 6 months follow-up period, four relapses were documented, one in the Sbv group (2%), one in the M+P group (2%) and two in the M+GM group (5%). Adverse events were documented in 65% of subjects from Sbv group, 79% of M+GM group and 76% of M+P group. Conclusions: Miltefosine is more effective than standard Sbv for the treatment of CL caused by L. braziliensis in Brazil and accelerate the healing time of CL. The association of Miltefosine with GM-CSF do not improve therapeutic outcome. (Clinicaltrials.gov Identifier NCT03023111).engOxford University Presshttps://www.arca.fiocruz.br/handle/icict/45507Leishmaniose cutâneaFator Estimulador de Colônias de Granulócitos e MacrófagosAntimônio pentavalenteLeishmania braziliensisCutaneous LeishmaniasisMiltefosineGM-CSFPentavalent antimonyLeishmania (V.) braziliensisA double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil (Preprint)info: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-83097https://www.arca.fiocruz.br/bitstream/icict/44288/1/license.txt36b51ef91c52b5338d9d29ba0cc807bcMD51ORIGINALMachado, Paulo A.L. A double....pdfMachado, Paulo A.L. 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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 (Preprint)
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 (Preprint)
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 (Preprint) Machado, Paulo Roberto Lima Leishmaniose cutânea Fator Estimulador de Colônias de Granulócitos e Macrófagos Antimônio pentavalente Leishmania braziliensis Cutaneous Leishmaniasis Miltefosine GM-CSF Pentavalent antimony Leishmania (V.) 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 (Preprint)
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 (Preprint)
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 (Preprint)
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 (Preprint)
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 (Preprint)
author	Machado, Paulo Roberto Lima
author_facet	Machado, Paulo Roberto Lima Prates, Fernanda V. O. Boaventura, Viviane Lago, Tainã Guimarães, Luiz H. Schriefer, Albert Corte, Temis W. F. Penna, Gerson Oliveira Barral, Aldina Maria Prado Barral Netto, Manoel Carvalho, Edgar Marcelino
author_role	author
author2	Prates, Fernanda V. O. Boaventura, Viviane Lago, Tainã Guimarães, Luiz H. Schriefer, Albert Corte, Temis W. F. Penna, Gerson Oliveira Barral, Aldina Maria 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 H. Schriefer, Albert Corte, Temis W. F. Penna, Gerson Oliveira Barral, Aldina Maria Prado Barral Netto, Manoel Carvalho, Edgar Marcelino
dc.subject.other.pt_BR.fl_str_mv	Leishmaniose cutânea Fator Estimulador de Colônias de Granulócitos e Macrófagos Antimônio pentavalente Leishmania braziliensis
topic	Leishmaniose cutânea Fator Estimulador de Colônias de Granulócitos e Macrófagos Antimônio pentavalente Leishmania braziliensis Cutaneous Leishmaniasis Miltefosine GM-CSF Pentavalent antimony Leishmania (V.) braziliensis
dc.subject.en.pt_BR.fl_str_mv	Cutaneous Leishmaniasis Miltefosine GM-CSF Pentavalent antimony Leishmania (V.) 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 a informação no documento.
publishDate	2020
dc.date.accessioned.fl_str_mv	2020-10-31T11:40:22Z
dc.date.available.fl_str_mv	2020-10-31T11:40:22Z
dc.date.issued.fl_str_mv	2020
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 Roberto Lima 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, p. 1-19, 2020.
dc.identifier.uri.fl_str_mv	https://www.arca.fiocruz.br/handle/icict/44288
dc.identifier.issn.pt_BR.fl_str_mv	1058-4838
dc.identifier.doi.pt_BR.fl_str_mv	10.1093/cid/ciaa1337
identifier_str_mv	MACHADO, Paulo Roberto Lima 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, p. 1-19, 2020. 1058-4838 10.1093/cid/ciaa1337
url	https://www.arca.fiocruz.br/handle/icict/44288
dc.language.iso.fl_str_mv	eng
language	eng
dc.relation.hasversion.pt_BR.fl_str_mv	https://www.arca.fiocruz.br/handle/icict/45507
dc.rights.driver.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	Oxford University Press
publisher.none.fl_str_mv	Oxford University Press
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)
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repository.name.fl_str_mv	Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv	repositorio.arca@fiocruz.br
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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 (Preprint)

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