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ACTIVE NOT RECRUITING
NCT02530697
PHASE2

The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil

Sponsor: University of Brasilia

View on ClinicalTrials.gov

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

DRUG

Meglumine antimoniate

20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.

DRUG

Miltefosine

Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.

DRUG

Pentoxifylline

Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.

Locations (1)

Hospital Universitário de Brasília

Brasília, Federal District, Brazil