Randomized Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis at Federal District, Brazil
Overview
- Phase
- Phase 2
- Intervention
- Standard Treatment Meglumine antimoniate
- Conditions
- Leishmaniasis
- Sponsor
- Brasilia University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Cure
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Detailed Description
Mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients with cutaneous leishmaniasis in the New World. It causes deformities and may be lethal if not treated. It is part of the neglected tropical diseases because on the past sixty years there was few progress regarding other treatment options or improvement at quality of life of its patients. Also, there was little interest from the pharmaceutical industry and government authorities to develop new researches. The standard treatment, meglumine antimoniate, is toxic, invasive, requires trained personnel and has many adverse effects and restrictions. On the other hand, miltefosine is the first oral drug to demonstrate efficacy against mucocutaneous leishmaniasis. Few clinical trials have being performed in Central and South American countries, but so far, just one involved mucosal leishmaniasis patients, and compared miltefosine to amphotericin B. None studies comparing its efficacy to the standard treatment have being done.
Investigators
Juliana Silva
Dr. Juliana Silva
Brasilia University Hospital
Eligibility 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
Arms & Interventions
Standard Treatment
Meglumine antimoniate as recommended by the Brazilian Ministry of Health
Intervention: Standard Treatment Meglumine antimoniate
Tested Intervention
Miltefosine as the tested intervention
Intervention: Miltefosine
Outcomes
Primary Outcomes
Cure
Time Frame: 6 months
Re-epithelizations of mucosal ulcers or regression of symptoms
Secondary Outcomes
- Adverse effects(6 months)