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Miltefosine for Children With PKDL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02193022
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

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%.

    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.

Condition or disease Intervention/treatment Phase
Post Kala Azar Dermal Leishmaniasis Drug: Miltefosine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Miltefosine

Arm Intervention/treatment
Experimental: Miltefosine Drug: Miltefosine



Primary Outcome Measures :
  1. 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. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   730 Days to 6569 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Bangladesh
International Centre for Diarrheal Disease Research, Bangladesh
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Thrasher Research Fund
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT02193022    
Other Study ID Numbers: PR-13045
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2018
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Bangladesh, PKDL, Visceral Leishmaniasis, Children, Miltefosine
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Miltefosine
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents