Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2016-01-31
2018-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
miltefosine plus intralesional pentamidine
miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
Interventions
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miltefosine plus intralesional pentamidine
miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
Eligibility Criteria
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Inclusion Criteria
* ≥ 12 years,
* parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material,
* no antileishmanial therapy in the last 3 months,
* no mucosal lesions,
* no history of significant concomitant diseases including immunosuppression.
12 Years
ALL
No
Sponsors
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Jonathan Berman
OTHER
Responsible Party
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Jonathan Berman
President
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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ABF MP
Identifier Type: -
Identifier Source: org_study_id
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