Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether miltefosine is effective in the treatment of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brasilia University Hospital
• Treatments: Meglumine Antimoniate; Miltefosine

Criteria

Inclusion Criteria:

• Clinical diagnosis of mucosal leishmaniasis

• Not previously treated, or last treatment must have occurred more than 6 months before the enrollment on the study

• Use of contraceptive method, if female on child bearing age

• Sign the agreement and consent form

Exclusion Criteria:

• Previous leishmanicidal treatment on the past 6 months before the enrollment on the study

• Electrocardiogram abnormalities on the pretreatment exams

• Previous kidney, liver and/or heart diseases

• Diabetes Mellitus

• Hypersensitivity to miltefosine or meglumine antimoniate

• Pregnant women or breastfeeding mothers

• Hiv patients