NCT02530697

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

The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Brasilia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leishmaniasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-08-01
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2015-08-21
• Last updated: 2024-01-16

Locations

1 site across 1 country: Brazil