Miltefosine for Children With PKDL (NCT02193022) | Clinical Trial Compass
CompletedPhase 3
Miltefosine for Children With PKDL
Bangladesh80 participantsStarted 2014-07
Plain-language 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.
Who can participate
Age range
730 Days – 6569 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1. Safety of 12 weeks treatment with Miltefosine at allometric dose in children ages < 18 years old.
Timeframe: 15 months
2
2. Cure rate of 12 weeks treatment with Miltefosine at allometric dose in children ages < 18 years old.
Timeframe: 15 months
Trial details
NCT IDNCT02193022
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh