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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02193022 |
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Date of registration:
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23/06/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Miltefosine for Children With PKDL
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Scientific title:
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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 |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02193022 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Bangladesh
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Key inclusion & exclusion criteria
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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
Age minimum:
730 Days
Age maximum:
6569 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Post Kala Azar Dermal Leishmaniasis
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Intervention(s)
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Drug: Miltefosine
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Primary Outcome(s)
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2. Cure rate of 12 weeks treatment with Miltefosine at allometric dose in children ages < 18 years old.
[Time Frame: 15 months]
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1. Safety of 12 weeks treatment with Miltefosine at allometric dose in children ages < 18 years old.
[Time Frame: 15 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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