Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

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.

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