Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children.

ABSTRACT:

Background

Children have a lower response rate to antimonial drugs and higher elimination rate of antimony (Sb) than adults. Oral miltefosine has not been evaluated for pediatric cutaneous leishmaniasis.

Methods

A randomized, noninferiority clinical trial with masked evaluation was conducted at 3 locations in Colombia where Leishmania panamensis and Leishmania guyanensis predominated. One hundred sixteen children aged 2-12 years with parasitologically confirmed cutaneous leishmaniasis were randomized to directly observed treatment with meglumine antimoniate (20 mg Sb/kg/d for 20 days; intramuscular) (n = 58) or miltefosine (1.8-2.5 mg/kg/d for 28 days; by mouth) (n = 58). Primary outcome was treatment failure at or before week 26 after initiation of treatment. Miltefosine wa

SUBMITTER: Rubiano LC 

PROVIDER: S-EPMC3266136 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature