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.

Abstract

Abstract. Clinical response to supervised treatment of Colombian patients with cutaneous 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-epithelialization 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 61% (28 of 46) compared to 67% (24 of 36) for 20 days. There was a significantly lower clinical response for children Ͻ 5 years in both 10-day (11%) and 20-day (25%) groups compared to patients aged 5-14 years (67% and 75%, respectively) and 15 years or more (81% and 83%, respectively). Overall efficacy of treatment schedules was comparable, but lower than expected, mainly because of low efficacy in children. Pathogenicity of infection and pharmacokinetics may affect the treatment response in children. New therapeutic alternatives should be evaluated in trials that include children and women.

In Vitro Sensitivity of Cutaneous Leishmania Promastigote Isolates Circulating in French Guiana to a Set of Drugs

“…2 In CL, the efficacy of antimonials varies: 94.2% in Bolivia, 3 84% in Brazil, 4 75.6-78% in Peru, 5,6 and 61-67% in Colombia. 7 The efficacy of pentamidine is 35% in Peru. 6 Other treatments have been used, such as amphotericin B as a first-or second-line treatment to cure VL, MCL, and CL.…”

Current diagnosis and treatment of cutaneous and mucocutaneous leishmaniasis

“…In the New World, the efficacy of anti monials for the treatment of cutaneous leishmaniasis has been variable. In Bolivia, treatment failure was observed in 7% of patients [78], in 16% in Brazil [79], and in 39% of patients in Colombia [80]. In the Old World, failure of this drug is approximately 13%, and this drug is considered as satisfactory for the treatment of cutaneous leishmaniasis.…”

Clinical and Epidemiologic Profile of Cutaneous Leishmaniasis in Colombian Children: Considerations for Local Treatment

“…The few studies that have been conducted have shown that children with CL have a lower response rate to pentavalent antimonial compounds and a significantly higher elimination rate of antimony compared with adults. 1,2 These circumstances coupled with the logistic, social, and economic barriers to access and adherence to 20 days of intramuscular injections limit the effectiveness of antimonial drugs, which remain the first-line treatment of CL in children. Miltefosine has recently been shown to be non-inferior to meglumine antimoniate in the treatment of pediatric CL in Colombia, 3 and its efficacy in children is corroborated by clinical trials in populations where Leishmania guyanensis and L. braziliensis are endemic in Brazil.…”