Status:
COMPLETED
Miltefosine for Children With PKDL
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Post Kala Azar Dermal Leishmaniasis
Eligibility:
All Genders
730-6569 years
Phase:
PHASE3
Brief 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%. ...
Detailed Description
Background: Visceral leishmaniasis also known as kala-azar is a neglected tropical disease affecting the poorest of the poor living in the rural areas of Bangladesh, Nepal, India, South Sudan, Sudan ...
Eligibility Criteria
Inclusion
- 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
- do not fulfill inclusion criteria
- lesions with mucosal involvement
- serious concomitant illness
- cannot be followed up
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02193022
Start Date
July 1 2014
End Date
June 30 2019
Last Update
August 21 2019
Active Locations (1)
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1
International Centre for Diarrheal Disease Research, Bangladesh
Dhaka, Bangladesh, 1212