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: Penna, Gerson de Oliveira
Data de Publicação: 2011
Outros Autores: Machado, Paulo Roberto Lima, Talhari, Sinésio, Talhari, Anette Chrusciak, Dietze, Reynaldo, Talhari, Carolina Chrusciak, Silva, Roberto Moreira da, Yamashita, Ellen Priscila Gadelha
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFBA
Texto Completo: http://repositorio.ufba.br/ri/handle/ri/14801
Resumo: Texto completo: acesso restrito. p. 255-260
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spelling Penna, Gerson de OliveiraMachado, Paulo Roberto LimaTalhari, SinésioTalhari, Anette ChrusciakDietze, ReynaldoTalhari, Carolina ChrusciakSilva, Roberto Moreira daYamashita, Ellen Priscila GadelhaMachado, Paulo Roberto LimaTalhari, SinésioPenna, Gerson de OliveiraMachado, Paulo Roberto LimaTalhari, SinésioTalhari, Anette ChrusciakDietze, ReynaldoTalhari, Carolina ChrusciakSilva, Roberto Moreira daYamashita, Ellen Priscila GadelhaMachado, Paulo Roberto LimaTalhari, Sinésio2014-04-08T13:38:23Z20110002-9637http://repositorio.ufba.br/ri/handle/ri/14801v. 84, n. 2Texto completo: acesso restrito. p. 255-260Miltefosine 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.Submitted by Edileide Reis (leyde-landy@hotmail.com) on 2014-04-08T13:38:23Z No. of bitstreams: 1 Gerson de Oliveira Penna.pdf: 753950 bytes, checksum: 20958639833bc3e1c7140fef4aa8bf07 (MD5)Made available in DSpace on 2014-04-08T13:38:23Z (GMT). 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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
dc.title.alternative.pt_BR.fl_str_mv American Journal of Tropical Medicine and Hygiene
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
Penna, Gerson de Oliveira
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 Penna, Gerson de Oliveira
author_facet Penna, Gerson de Oliveira
Machado, Paulo Roberto Lima
Talhari, Sinésio
Talhari, Anette Chrusciak
Dietze, Reynaldo
Talhari, Carolina Chrusciak
Silva, Roberto Moreira da
Yamashita, Ellen Priscila Gadelha
author_role author
author2 Machado, Paulo Roberto Lima
Talhari, Sinésio
Talhari, Anette Chrusciak
Dietze, Reynaldo
Talhari, Carolina Chrusciak
Silva, Roberto Moreira da
Yamashita, Ellen Priscila Gadelha
author2_role author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Penna, Gerson de Oliveira
Machado, Paulo Roberto Lima
Talhari, Sinésio
Talhari, Anette Chrusciak
Dietze, Reynaldo
Talhari, Carolina Chrusciak
Silva, Roberto Moreira da
Yamashita, Ellen Priscila Gadelha
Machado, Paulo Roberto Lima
Talhari, Sinésio
Penna, Gerson de Oliveira
Machado, Paulo Roberto Lima
Talhari, Sinésio
Talhari, Anette Chrusciak
Dietze, Reynaldo
Talhari, Carolina Chrusciak
Silva, Roberto Moreira da
Yamashita, Ellen Priscila Gadelha
Machado, Paulo Roberto Lima
Talhari, Sinésio
description Texto completo: acesso restrito. p. 255-260
publishDate 2011
dc.date.issued.fl_str_mv 2011
dc.date.accessioned.fl_str_mv 2014-04-08T13:38:23Z
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.uri.fl_str_mv http://repositorio.ufba.br/ri/handle/ri/14801
dc.identifier.issn.none.fl_str_mv 0002-9637
dc.identifier.number.pt_BR.fl_str_mv v. 84, n. 2
identifier_str_mv 0002-9637
v. 84, n. 2
url http://repositorio.ufba.br/ri/handle/ri/14801
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
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dc.source.pt_BR.fl_str_mv http://dx.doi.org/ 10.4269/ajtmh.2011.10-0155
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