Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil

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.

Detalhes bibliográficos
Autores: Chrusciak-Talhari, Anette, Dietze, Reynaldo, Talhari, Carolina Chrusciak, Silva, Roberto Moreira da, Yamashita, Ellen Priscila Gadelha, Penna, Gerson de Oliveira, Machado, Paulo Roberto Lima, Talhari, Sinésio
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2011
País:Brasil
Recursos:Fundação Oswaldo Cruz (FIOCRUZ)
Repositorio:Repositório Institucional da FIOCRUZ (ARCA)
Idioma:inglés
OAI Identifier:oai:arca.fiocruz.br:icict/41383
Acesso em linha:https://arca.fiocruz.br/handle/icict/41383
Access Level:acceso abierto
Palavra-chave:Antiprotozoal Agents
Leishmania guyanensis
Leishmaniasis, Mucocutaneous
Meglumine
Meglumine Antimoniate
Organometallic Compounds
Phosphorylcholine
Treatment Outcome
Leishmaniasis
Miltefosine
Treatment outcome
Brazil
Leishmaniose
Leishmaniose Mucocutânea
Resultado do Tratamento
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dc.title.none.fl_str_mv Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil
title Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil
spellingShingle Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil
Chrusciak-Talhari, Anette
Antiprotozoal Agents
Leishmania guyanensis
Leishmaniasis, Mucocutaneous
Meglumine
Meglumine Antimoniate
Organometallic Compounds
Phosphorylcholine
Treatment Outcome
Leishmaniasis
Miltefosine
Leishmania guyanensis
Treatment outcome
Brazil
Leishmaniose
Leishmaniose Mucocutânea
Leishmania guyanensis
Resultado do Tratamento
title_short Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil
title_full Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil
title_fullStr Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil
title_full_unstemmed Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil
title_sort Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil
dc.creator.none.fl_str_mv Chrusciak-Talhari, Anette
Dietze, Reynaldo
Talhari, Carolina Chrusciak
Silva, Roberto Moreira da
Yamashita, Ellen Priscila Gadelha
Penna, Gerson de Oliveira
Machado, Paulo Roberto Lima
Talhari, Sinésio
author Chrusciak-Talhari, Anette
author_facet Chrusciak-Talhari, Anette
Dietze, Reynaldo
Talhari, Carolina Chrusciak
Silva, Roberto Moreira da
Yamashita, Ellen Priscila Gadelha
Penna, Gerson de Oliveira
Machado, Paulo Roberto Lima
Talhari, Sinésio
author_role author
author2 Dietze, Reynaldo
Talhari, Carolina Chrusciak
Silva, Roberto Moreira da
Yamashita, Ellen Priscila Gadelha
Penna, Gerson de Oliveira
Machado, Paulo Roberto Lima
Talhari, Sinésio
author2_role author
author
author
author
author
author
author
dc.subject.mesh.none.fl_str_mv Antiprotozoal Agents
Leishmania guyanensis
Leishmaniasis, Mucocutaneous
Meglumine
Meglumine Antimoniate
Organometallic Compounds
Phosphorylcholine
Treatment Outcome
topic Antiprotozoal Agents
Leishmania guyanensis
Leishmaniasis, Mucocutaneous
Meglumine
Meglumine Antimoniate
Organometallic Compounds
Phosphorylcholine
Treatment Outcome
Leishmaniasis
Miltefosine
Leishmania guyanensis
Treatment outcome
Brazil
Leishmaniose
Leishmaniose Mucocutânea
Leishmania guyanensis
Resultado do Tratamento
dc.subject.en.none.fl_str_mv Leishmaniasis
Miltefosine
Leishmania guyanensis
Treatment outcome
Brazil
dc.subject.decs.none.fl_str_mv Leishmaniose
Leishmaniose Mucocutânea
Leishmania guyanensis
Resultado do Tratamento
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 2011
dc.date.issued.fl_str_mv 2011
dc.date.accessioned.fl_str_mv 2020-05-25T17:37:37Z
dc.date.available.fl_str_mv 2020-05-25T17:37:37Z
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 CHRUSCIAK-TALHARI, Anette et al. Randomized controlled clinical trial to access efficacy and safety of Miltefosine in the treatment of Cutaneous Leishmaniasis caused by Leishmania (Viannia) guyanensis in Manaus, Brazil. The American Journal of Tropical Medicine and Hygiene, v. 84, n. 2, p. 255–260, Feb. 2011.
dc.identifier.uri.fl_str_mv https://arca.fiocruz.br/handle/icict/41383
dc.identifier.issn.none.fl_str_mv 0002-9637
dc.identifier.doi.none.fl_str_mv 10.4269/ajtmh.2011.10-0155
dc.identifier.eissn.none.fl_str_mv 1476-1645
identifier_str_mv CHRUSCIAK-TALHARI, Anette et al. Randomized controlled clinical trial to access efficacy and safety of Miltefosine in the treatment of Cutaneous Leishmaniasis caused by Leishmania (Viannia) guyanensis in Manaus, Brazil. The American Journal of Tropical Medicine and Hygiene, v. 84, n. 2, p. 255–260, Feb. 2011.
0002-9637
10.4269/ajtmh.2011.10-0155
1476-1645
url https://arca.fiocruz.br/handle/icict/41383
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 American Society of Tropical Medicine and Hygiene
publisher.none.fl_str_mv American Society of Tropical Medicine and Hygiene
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
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spelling 2020-05-25T17:37:37Z2020-05-25T17:37:37Z2011CHRUSCIAK-TALHARI, Anette et al. Randomized controlled clinical trial to access efficacy and safety of Miltefosine in the treatment of Cutaneous Leishmaniasis caused by Leishmania (Viannia) guyanensis in Manaus, Brazil. The American Journal of Tropical Medicine and Hygiene, v. 84, n. 2, p. 255–260, Feb. 2011.0002-9637https://arca.fiocruz.br/handle/icict/4138310.4269/ajtmh.2011.10-01551476-1645Gerson 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.This study is part of a National Multicenter Clinical Trial for the evaluation of miltefosine in the treatment of cutaneous leishmaniasis caused by L. ( V. ) guyanensis and L. ( V. ) braziliensis. Both studies were conducted in Brazil. The current study was funded by FINEP/Brazil (project no. 3726/05) and coordinated by the Núcleo de Medicina Tropical from the University of Brasília, Brasília, DF, Brazil. The present manuscript refers to the study arm performed at the Fundação de Medicina Tropical do Amazonas with patients infected with L. ( V. ) guyanensis . The other arm was conducted at the Immunology Service of the University Hospital Professor Edgar Santos at the Federal University of Bahia, on patients infected with L. ( V. ) braziliensis with financial support of CNPq no. 410559/2006-7 (edital mct/cnpq/ms/sctie/decit 25/2006). Miltefosine (Impavido), was supplied by Zentaris GmbH (presently Aeterna Zentaris GmbH).Fundação de Medicina Tropical do Amazonas. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Universidade Federal do Espírito Santo. Núcleo de Doenças Infecciosas. Vitória, ES, Brasil.Fundação de Medicina Tropical do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical do Amazonas. Manaus, AM, Brasil.Universidade de Brasília. Faculdade de Medicina. Núcleo de Medicina Tropical. Brasília, DF, Brasil / Fundação Oswaldo Cruz. Fiocruz Brasília. Brasília, DF, Brasil.Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Salvador, BA, Brasil.Fundação de Medicina Tropical do Amazonas. Manaus, AM, Brasil.Miltefosine has been used in the treatment of several new world cutaneous leishmaniasis (CL) species with variable efficacy. Our study is the first evidence on its clinical efficacy in Leishmania (Viannia) guyanensis. In this phase II/III randomized clinical trial, 90 CL patients were randomly allocated (2:1) to oral miltefosine (2.5 mg/kg/day/28 days) (N = 60) or parenteral antimony (15-20 mg/Sb/kg/day/20 days) (N = 30) according to age groups: 2-12 y/o and 13-65 y/o. Patients were human immunodeficiency virus (HIV) noninfected parasitological proven CL without previous treatment. Definitive cure was accessed at 6 months follow-up visit. No severe adverse events occurred. Vomiting was the most frequent adverse event (48.3%) followed by nausea (8.6%) and diarrhea (6.7%). Cure rates were 71.4% (95% confidence interval [CI] = 57.8-82.7) and 53.6% (95% CI = 33.9-72.5) (P = 0.05) for miltefosine and antimonial, respectively. There were no differences in cure rates between age groups within the same treatment arms. Miltefosine was safe and relatively well tolerated and cure rate was higher than antimony.engAmerican Society of Tropical Medicine and HygieneAntiprotozoal AgentsLeishmania guyanensisLeishmaniasis, MucocutaneousMeglumineMeglumine AntimoniateOrganometallic CompoundsPhosphorylcholineTreatment OutcomeLeishmaniasisMiltefosineLeishmania guyanensisTreatment outcomeBrazilLeishmanioseLeishmaniose MucocutâneaLeishmania guyanensisResultado do TratamentoRandomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZChrusciak-Talhari, AnetteDietze, ReynaldoTalhari, Carolina ChrusciakSilva, Roberto Moreira daYamashita, Ellen Priscila GadelhaPenna, Gerson de OliveiraMachado, Paulo Roberto LimaTalhari, SinésioLICENSElicense.txtlicense.txttext/plain; charset=utf-83074https://arca.fiocruz.br/bitstreams/2e9354e6-8544-41eb-9be6-d34ad01ec32f/downloadd3e717dbb24bfc607ede047f44d29a0eMD51falseAnonymousREADORIGINALve_Anette_Talhari_etal.pdfve_Anette_Talhari_etal.pdfapplication/pdf756809https://arca.fiocruz.br/bitstreams/76bf8093-2c9d-4e8c-9830-3fd0de06f2d9/download98684c6a2e3d12785161195dd4ff6b55MD52trueAnonymousREADTEXTve_Anette_Talhari_etal.pdf.txtve_Anette_Talhari_etal.pdf.txtExtracted texttext/plain36228https://arca.fiocruz.br/bitstreams/8c3bcddb-a788-4fa0-97ff-7bb7dfd132bc/download42cd6831cf84fdc5e700bf0cd230dfdbMD58falseAnonymousREADTHUMBNAILcapa_page-0001.jpgcapa_page-0001.jpgimage/jpeg1290541https://arca.fiocruz.br/bitstreams/8e67e622-633f-487c-8872-a65c461a7d14/download339fc8a864ceaa1fac1804bd71a45c2dMD54falseAnonymousREADve_Anette_Talhari_etal.pdf.jpgve_Anette_Talhari_etal.pdf.jpgGenerated Thumbnailimage/jpeg46281https://arca.fiocruz.br/bitstreams/71ea94b9-87d4-48bc-9fb4-0219439649fb/downloadfd675db25a5c9f37c6b43298a4ba1ec8MD59falseAnonymousREADicict/413832025-12-10 14:21:37.246open.accessoai:arca.fiocruz.br:icict/41383https://arca.fiocruz.brRepositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352025-12-10T17:21:37Repositório Institucional da FIOCRUZ (ARCA) - 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