Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas
• Collaborators: INS; Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS); Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta
• Treatments: Meglumine Antimoniate; Miltefosine

Criteria

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