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Miltefosine for Children With PKDL

NCT02193022 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-08-21

No results posted yet for this study

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.

Conditions

  • Post Kala Azar Dermal Leishmaniasis

Interventions

DRUG

Miltefosine

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
730 Days
Max Age
6569 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02193022 on ClinicalTrials.gov