Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

Brasilia University Hospital

Status and phase: Completed; Phase 2

Conditions: Leishmaniasis, Mucocutaneous; Leishmaniasis

Treatments: Drug: Standard Treatment Meglumine antimoniate; Drug: Miltefosine

Study type: Interventional

Funder types: Other

Identifiers

NCT01377974

MILTHUB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 12 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Standard Treatment

Active Comparator group

Description:

Meglumine antimoniate as recommended by the Brazilian Ministry of Health

Treatment:

Drug: Standard Treatment Meglumine antimoniate

Tested Intervention

Experimental group

Description:

Miltefosine as the tested intervention

Treatment:

Drug: Miltefosine