Miltefosine for Children With PKDL

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborator: Thrasher Research Fund
• Treatments: Miltefosine

Criteria

Inclusion Criteria:

• a child of either sex, treated for VL in the past, currently with skin lesions like PKDL, positive for rK39 test, and positive for Leishmania LD bodies by microscopy and / DNA by qPCR in their skin specimens

• more than 2 years and less than 18 years old

• clinically healthy and free from other chronic illness

• received no treatment for PKDL in the last 6 months

• normal hepatic, renal, and hematological functions

• parent / guardian provided informed voluntary written consent for his/her child participation

Exclusion Criteria:

• do not fulfill inclusion criteria

• lesions with mucosal involvement

• serious concomitant illness

• cannot be followed up