Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

Phase 3

• Conditions: Cutaneous Leishmaniasis
• Interventions: Drug: Miltefosine; Drug: Meglumine antimoniate

• Registration Number: NCT00487253
• Lead Sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-14
• Study First Submitted QC: 2007-06-15
• Study First Posted: 2007-06-18
• Study Start: 2007-07
• Status Verified: 2010-02
• Primary Completion: 2010-02
• Last Update Submitted: 2010-02-13
• Last Update Posted: 2010-02-17
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Miltefosine	Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days. presentation: capsulas 10mg and 50mg Miltefosine (Impavido®)
Group 2	Meglumine antimoniate	Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days.

Primary Outcome Measures

Name	Time	Method
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.	26 weeks (6 months)
Evidence of clinical or laboratory toxicity during the treatment period.	During the treatment period (20 or 28 days)

Secondary Outcome Measures

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