Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

Centro Internacional de Entrenamiento e Investigaciones Médicas150 enrolled

Overview

The purpose of this randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric Cutaneous caused by L. Viannia species in Colombia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Cutaneous Leishmaniasis

Interventions

MiltefosineDRUG

Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.

Meglumine antimoniateDRUG

Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 2 to 12 years of age (inclusive) * Parasitologically confirmed CL * Availability to receive supervised treatment for 28 days (i.e., directly observed therapy, to ensure the therapy is appropriately administered and received - e.g., the miltefosine is "swallowed") * Availability to return for follow-up visits for at least 6 months after treatment is initiated Exclusion Criteria: * Weight under 10kg * Previous use of SbV, miltefosine or other antileishmanial therapy * Simultaneous mucosal lesions suggestive of or proven to be mucosal leishmaniasis * If a girl, ability to reproduce (history of menarche) * Relative or absolute contraindications for the use of SbV drugs or miltefosine, including history of cardiac, renal or hepatic disease * Patients with pretreatment haemoglobin \<10g/dl or blood urea nitrogen (BUN), serum creatinine, ALT, AST or amylase values that exceed the upper limit of normal * If living in Malaria endemic areas (eg. Tumaco) only: A positive malaria thick smear

Outcomes

Primary Outcomes

The primary outcome measure will be the proportion of "Therapeutic Failures" diagnosed during the final (week 26) visit or before, according to defined clinical criteria.

Time frame: 26 weeks (6 months)

Evidence of clinical or laboratory toxicity during the treatment period.

Time frame: During the treatment period (20 or 28 days)

Secondary Outcomes

Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment.

Time frame: 26 weeks

Data from ClinicalTrials.gov

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