Treatment failure in children in a randomized clinical trial with 10 and 20 days of meglumine antimonate for cutaneous leishmaniasis due to Leishmania viannia species

Clinical response to supervised treatment of Colombian patients with cutane ous leishmaniasis was evaluated in a randomized controlled trial comparing 10 days versus 20 days of treatment with meglumine antimonate (20 mg Sb/kg/ day). Masked examiners evaluated clinical response defined as 100% re-epith elialization of all lesions at 13 weeks and no relapses during 52 weeks of follow-up. The efficacy of meglumine antimonate for 10 days treatment was 6 1%, (28 of 46) compared to 67% (24 of 36) for 20 days. There was a signific antly lower clinical response for children < 5 years in both 10-day (11%) a nd 20-day (25%) groups compared to patients aged 5-14 years (67% and 75%, r espectively) and 15 years or more (81% and 83%, respectively). Overall effi cacy of treatment schedules was comparable, but lower than expected, mainly because of low efficacy in children. Pathogenicity of infection and pharma cokinetics may affect the treatment response in children. New therapeutic a lternatives should be evaluated in trials that include children and women.