Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

AB Foundation80 enrolled

Overview

Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L braziliensis in Bolivia and cutaneous leishmaniasis due to L panamensis in Colombia. This trial is intended to evaluate miltefosine for cutaneous leishmaniasis due to L braziliensis in Bolivia. Patients will be randomly assigned to miltefosine or pentavalent antimony. Standard dose regimens will be used for both drugs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cutaneous Leishmaniasis

Interventions

miltefosineDRUG

antimonyDRUG

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

Presentation: At least 1 lesion must be ulcerative. Parasitology: Parasitological confirmation of 1 lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion. Previous RX: No specific or putatively specific therapy for leishmaniasis (Sb, pentamidine, amphotericin B, imidazoles, allopurinol) Other diseases: No concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (SGOT) and kidney function tests (creatinine).

Locations (1)

Puesto de Salud, Campamento OSCAR,

Palos Blancos, Bolivia

Outcomes

Primary Outcomes

cure rate

Data from ClinicalTrials.gov

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