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The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil
Sponsor: University of Brasilia
Summary
Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.
Official title: The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2015-08
Completion Date
2026-08
Last Updated
2024-01-16
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Hospital Universitário de Brasília
Brasília, Federal District, Brazil