Leishmaniasis, Leishmaniasis, Mucocutaneous
Conditions
Keywords
Leishmaniasis, Mucocutaneous Leishmaniasis, Therapeutics, meglumine antimoniate, miltefosine
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.
Interventions
DRUGMiltefosine
1 Capsule of 50mg, taken orally 2 times a day for 28 days
DRUGStandard Treatment Meglumine antimoniate
20mgKg daily intravenous Meglumine antimoniate as oriented by the Brazilian Ministry of Health
Sponsors
Brasilia University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure | 6 months | Re-epithelizations of mucosal ulcers or regression of symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 6 months | laboratory tests of blood, kidney, liver and cardiac functions, partients will be asked about nausea, vomiting, diarrhea, myalgia, or other symptoms |
Countries
Brazil
Outcome results
None listed