The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil
NCT ID: NCT02530697
Last Updated: 2024-01-16
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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ACTIVE_NOT_RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2015-08-31
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 - Mucosal Antimoniate and Pentoxifylline
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days.
Meglumine antimoniate
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.
Pentoxifylline
Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
Group 2 - Mucosal Miltefosine and Pentoxifylline
Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days.
Miltefosine
Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.
Pentoxifylline
Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
Group 3 - Cutaneous Antimoniate and Pentoxifylline
20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days.
Meglumine antimoniate
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.
Pentoxifylline
Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
Group 4 - Cutaneous Miltefosine and Pentoxifylline
Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days.
Miltefosine
Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.
Pentoxifylline
Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
Interventions
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Meglumine antimoniate
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.
Miltefosine
Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.
Pentoxifylline
Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
* Ages between 18 and 80 years old;
* Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
* Agree to participate in the study and sign the informed consent term.
Exclusion Criteria
* Clinical or laboratorial evidences of electrocardiographic disorders;
* Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
* Hypersensitivity to meglucamine antimoniate;
* Pregnancy or lactation;
* Fertile females that do not agree to use contraceptive methods;
* Patients that do not agree to the informed consent term.
18 Years
80 Years
ALL
No
Sponsors
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University of Brasilia
OTHER
Responsible Party
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SOFIA SALES MARTINS
MD, PhD
Locations
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Hospital Universitário de Brasília
Brasília, Federal District, Brazil
Countries
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Other Identifiers
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40068714.1.0000.5558
Identifier Type: -
Identifier Source: org_study_id
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