Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

Centro Internacional de Entrenamiento e Investigaciones Médicas

Status and phase: Unknown; Phase 3

Conditions: Cutaneous Leishmaniasis

Treatments: Drug: Miltefosine; Drug: Meglumine antimoniate

Study type: Interventional

Funder types: Other

Identifiers

NCT00487253

50100119

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days. presentation: capsulas 10mg and 50mg Miltefosine (Impavido®)

Treatment:

Drug: Miltefosine

Group 2

Active Comparator group

Description:

Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days.

Treatment:

Drug: Meglumine antimoniate