Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leishmaniasis Leishmaniasis, Mucocutaneous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Treatment

Meglumine antimoniate as recommended by the Brazilian Ministry of Health

Group Type ACTIVE_COMPARATOR

Standard Treatment Meglumine antimoniate

Intervention Type DRUG

20mgKg daily intravenous Meglumine antimoniate as oriented by the Brazilian Ministry of Health

Tested Intervention

Miltefosine as the tested intervention

Group Type EXPERIMENTAL

Miltefosine

Intervention Type DRUG

1 Capsule of 50mg, taken orally 2 times a day for 28 days

Interventions

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Miltefosine

1 Capsule of 50mg, taken orally 2 times a day for 28 days

Intervention Type DRUG

Standard Treatment Meglumine antimoniate

20mgKg daily intravenous Meglumine antimoniate as oriented by the Brazilian Ministry of Health

Intervention Type DRUG

Other Intervention Names

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Impavido pentavalent antimonial

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No