Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
Overview
- Phase
- Phase 3
- Intervention
- Miltefosine
- Conditions
- Cutaneous Leishmaniasis
- Sponsor
- Centro Internacional de Entrenamiento e Investigaciones Médicas
- Enrollment
- 150
- Primary Endpoint
- 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.
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Group 1
Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days. presentation: capsulas 10mg and 50mg Miltefosine (Impavido®)
Intervention: Miltefosine
Group 2
Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days.
Intervention: Meglumine antimoniate
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.(26 weeks)