Miltefosine for Children With PKDL
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|ClinicalTrials.gov Identifier: NCT02193022|
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : August 21, 2019
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%.
- 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.
- Nutritional & environmental factors such as low serum vitamin E, A, D, Zn & arsenic exposure are associated with PKDL.
|Condition or disease||Intervention/treatment||Phase|
|Post Kala Azar Dermal Leishmaniasis||Drug: Miltefosine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study for Safety and Efficacy of Miltefosine for Treatment of Children and Adolescents With Post-Kala-azar Dermal Leishmaniasis (PKDL) in Bangladesh and Association of Serum Vitamin E and Exposure to Arsenic With PKDL|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||June 30, 2019|
|Actual Study Completion Date :||June 30, 2019|
- 1. Safety of 12 weeks treatment with Miltefosine at allometric dose in children ages < 18 years old. [ Time Frame: 15 months ]Safety will be measured by the frequency of the adverse events.
- 2. Cure rate of 12 weeks treatment with Miltefosine at allometric dose in children ages < 18 years old. [ Time Frame: 15 months ]Cure will be defined by the resolution of skin lesion by ≥ 90% and skin and blood specimens negative for leishmania donovani bodies and leishmania DNA at 12 months after treatment.
- Find out the genetic susceptibility to PKDL through evaluation of the association of PKDL development with IL-10 and INF-gamma gene polymorphism. [ Time Frame: 15 months ]This will be measured by the association by PKDL and above mentioned genetic polymorphism. Here matched children who will be found during cross sectional survey for PKDL suspects will serve as controls.
- Find out the association of developing PKDL with host nutritional factor such as vitamin E, A, D and Zn status and exposure to environmental toxin such as arsenic. [ Time Frame: 15 months ]This will be measured by investigating the association of each of these nutritional factors and arsenic with the development of PKDL where matched children without PKDL will serve as control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193022
|International Centre for Diarrheal Disease Research, Bangladesh|
|Dhaka, Bangladesh, 1212|