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.
Phase:
Phase 3
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh