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https://www.arca.fiocruz.br/handle/icict/41383
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
Affilliation
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.
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.
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.
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