Miltefosine for Children With PKDL

Summary

Hypothesis: Primary hypothesis: 1. Oral treatment with Miltefosine in children with PKDL at allometric daily dose (based on body weight and height) for 12 weeks is safe with a cure rate of ≥95%. Secondary hypothesis: 2. Development of PKDL in children and adolescent is genetically predisposed and is associated with IL-10 \& IFN-gamma gene polymorphism causing high and low serum level of IL-10 and IFN-gamma respectively. 3. Nutritional \& environmental factors such as low serum vitamin E, A, D, Zn \& arsenic exposure are associated with PKDL.

Timeline

Start

2014-07

Primary completion

2019-06-30

Completion

2019-06-30

Publications

• Background Chrusciak-Talhari A, Dietze R, Chrusciak Talhari C, da Silva RM, Gadelha Yamashita EP, de Oliveira Penna G, Lima Machado PR, Talhari S. 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. Am J Trop Med Hyg. 2011 Feb;84(2):255-60. doi: 10.4269/ajtmh.2011.10-0155.
• Mondal D, Hasnain MG, Hossain MS, Ghosh D, Ghosh P, Hossain H, Baker J, Nath R, Haque R, Matlashewski G, Hamano S. Study on the safety and efficacy of miltefosine for the treatment of children and adolescents with post-kala-azar dermal leishmaniasis in Bangladesh, and an association of serum vitamin E and exposure to arsenic with post-kala-azar dermal leishmaniasis: an open clinical trial and case-control study protocol. BMJ Open. 2016 May 17;6(5):e010050. doi: 10.1136/bmjopen-2015-010050.

Drugs

Indications