Miltefosine for Children With PKDL

NCT02193022 | Completed Phase 3 DMC

• 1 other identifier: PR-13045
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Primary hypothesis:

1. 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%.
2. 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. 3.Nutritional \& environmental factors such as low serum vitamin E, A, D, Zn \& arsenic exposure are associated with PKDL.

Conditions

Post Kala Azar Dermal Leishmaniasis

Keywords

Bangladesh, PKDL, Visceral Leishmaniasis, Children, Miltefosine

Outcome Measures

Primary Outcomes (2)

• 1. Safety of 12 weeks treatment with Miltefosine at allometric dose in children ages < 18 years old.

  Safety will be measured by the frequency of the adverse events.

  15 months

• 2. Cure rate of 12 weeks treatment with Miltefosine at allometric dose in children ages < 18 years old.

  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.

  15 months

Other Outcomes (2)

• Find out the genetic susceptibility to PKDL through evaluation of the association of PKDL development with IL-10 and INF-gamma gene polymorphism.

  15 months

• 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.

  15 months

Study Arms (1)

Miltefosine

EXPERIMENTAL

Drug: Miltefosine

Interventions

Miltefosine DRUG

Miltefosine

Eligibility Criteria

• Age: 730 Days - 6569 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• lesions with mucosal involvement
• serious concomitant illness
• cannot be followed up

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

International Centre for Diarrheal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

Related Publications (2)

• Chrusciak-Talhari A, Dietze R, Chrusciak Talhari C, da Silva RM, Gadelha Yamashita EP, de Oliveira Penna G, Lima Machado PR, Talhari S. Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil. Am J Trop Med Hyg. 2011 Feb;84(2):255-60. doi: 10.4269/ajtmh.2011.10-0155.

  PMID: 21292895 BACKGROUND

• Mondal D, Hasnain MG, Hossain MS, Ghosh D, Ghosh P, Hossain H, Baker J, Nath R, Haque R, Matlashewski G, Hamano S. Study on the safety and efficacy of miltefosine for the treatment of children and adolescents with post-kala-azar dermal leishmaniasis in Bangladesh, and an association of serum vitamin E and exposure to arsenic with post-kala-azar dermal leishmaniasis: an open clinical trial and case-control study protocol. BMJ Open. 2016 May 17;6(5):e010050. doi: 10.1136/bmjopen-2015-010050.

  PMID: 27188804 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

miltefosine

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: July 17, 2014
• Study Start: July 1, 2014
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 21, 2019

Record last verified: 2018-08

Locations

BA (1)