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

Detalhes bibliográficos
Autor(a) principal: Chrusciak-Talhari, Anette
Data de Publicação: 2011
Outros Autores: Dietze, Reynaldo, Talhari, Carolina, Silva, Roberto Moreira da, Yamashita, Ellen Priscila Gadelha, Penna, Gerson Oliveira, Machado, Paulo Roberto Lima, Talhari, Sinésio
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/41383
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 Chrusciak-Talhari, AnetteDietze, ReynaldoTalhari, CarolinaSilva, Roberto Moreira daYamashita, Ellen Priscila GadelhaPenna, Gerson OliveiraMachado, Paulo Roberto LimaTalhari, Sinésio2020-05-25T17:37:37Z2020-05-25T17:37:37Z2011CHRUSCIAK-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. American Journal of Tropical Medicine and Hygine, [Bethesda], v. 84, n. 2, p. 255–260, feb. 2011.0002-9637https://www.arca.fiocruz.br/handle/icict/4138310.4269/ajtmh.2011.10-0155Gerson 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.FINEP / CNPqFundação 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.engThe American 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:FIOCRUZLICENSElicense.txtlicense.txttext/plain; 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dc.title.pt_BR.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
author Chrusciak-Talhari, Anette
author_facet Chrusciak-Talhari, Anette
Dietze, Reynaldo
Talhari, Carolina
Silva, Roberto Moreira da
Yamashita, Ellen Priscila Gadelha
Penna, Gerson Oliveira
Machado, Paulo Roberto Lima
Talhari, Sinésio
author_role author
author2 Dietze, Reynaldo
Talhari, Carolina
Silva, Roberto Moreira da
Yamashita, Ellen Priscila Gadelha
Penna, Gerson Oliveira
Machado, Paulo Roberto Lima
Talhari, Sinésio
author2_role author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Chrusciak-Talhari, Anette
Dietze, Reynaldo
Talhari, Carolina
Silva, Roberto Moreira da
Yamashita, Ellen Priscila Gadelha
Penna, Gerson Oliveira
Machado, Paulo Roberto Lima
Talhari, Sinésio
dc.subject.mesh.pt_BR.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.pt_BR.fl_str_mv Leishmaniasis
Miltefosine
Leishmania guyanensis
Treatment outcome
Brazil
dc.subject.decs.pt_BR.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
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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. American Journal of Tropical Medicine and Hygine, [Bethesda], v. 84, n. 2, p. 255–260, feb. 2011.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/41383
dc.identifier.issn.pt_BR.fl_str_mv 0002-9637
dc.identifier.doi.none.fl_str_mv 10.4269/ajtmh.2011.10-0155
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. American Journal of Tropical Medicine and Hygine, [Bethesda], v. 84, n. 2, p. 255–260, feb. 2011.
0002-9637
10.4269/ajtmh.2011.10-0155
url https://www.arca.fiocruz.br/handle/icict/41383
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language eng
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dc.publisher.none.fl_str_mv The American Society of Tropical Medicine and Hygiene
publisher.none.fl_str_mv The American Society of Tropical Medicine and Hygiene
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
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