| Author | Chrusciak-Talhari, Anette | |
| Author | Dietze, Reynaldo | |
| Author | Talhari, Carolina Chrusciak | |
| Author | Silva, Roberto Moreira da | |
| Author | Yamashita, Ellen Priscila Gadelha | |
| Author | Penna, Gerson de Oliveira | |
| Author | Machado, Paulo Roberto Lima | |
| Author | Talhari, Sinésio | |
| Access date | 2020-05-25T17:37:37Z | |
| Available date | 2020-05-25T17:37:37Z | |
| Document date | 2011 | |
| Citation | 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. | pt_BR |
| ISSN | 0002-9637 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/41383 | |
| 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. | pt_BR |
| Sponsorship | 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). | pt_BR |
| Language | eng | pt_BR |
| Publisher | American Society of Tropical Medicine and Hygiene | pt_BR |
| Rights | open access | pt_BR |
| MeSH | Antiprotozoal Agents | pt_BR |
| MeSH | Leishmania guyanensis | pt_BR |
| MeSH | Leishmaniasis, Mucocutaneous | pt_BR |
| MeSH | Meglumine | pt_BR |
| MeSH | Meglumine Antimoniate | pt_BR |
| MeSH | Organometallic Compounds | pt_BR |
| MeSH | Phosphorylcholine | pt_BR |
| MeSH | Treatment Outcome | pt_BR |
| 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 | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.4269/ajtmh.2011.10-0155 | |
| Abstract | 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. | pt_BR |
| Affilliation | Fundação de Medicina Tropical do Amazonas. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil. | pt_BR |
| Affilliation | Universidade Federal do Espírito Santo. Núcleo de Doenças Infecciosas. Vitória, ES, Brasil. | pt_BR |
| Affilliation | Fundação de Medicina Tropical do Amazonas. Manaus, AM, Brasil. | pt_BR |
| Affilliation | Fundação de Medicina Tropical do Amazonas. Manaus, AM, Brasil. | pt_BR |
| Affilliation | Fundação de Medicina Tropical do Amazonas. Manaus, AM, Brasil. | pt_BR |
| Affilliation | Universidade de Brasília. Faculdade de Medicina. Núcleo de Medicina Tropical. Brasília, DF, Brasil / Fundação Oswaldo Cruz. Fiocruz Brasília. Brasília, DF, Brasil. | pt_BR |
| Affilliation | Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Salvador, BA, Brasil. | pt_BR |
| Affilliation | Fundação de Medicina Tropical do Amazonas. Manaus, AM, Brasil. | pt_BR |
| Subject | Leishmaniasis | pt_BR |
| Subject | Miltefosine | pt_BR |
| Subject | Leishmania guyanensis | pt_BR |
| Subject | Treatment outcome | pt_BR |
| Subject | Brazil | pt_BR |
| DeCS | Leishmaniose | pt_BR |
| DeCS | Leishmaniose Mucocutânea | pt_BR |
| DeCS | Leishmania guyanensis | pt_BR |
| DeCS | Resultado do Tratamento | pt_BR |
| e-ISSN | 1476-1645 | |
