Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

Study Overview
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Brief Summary
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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.

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

Conditions
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Cutaneous Leishmaniasis

Intervention / Treatment
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* Drug: Miltefosine
* Drug: Meglumine antimoniate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days. presentation: capsulas 10mg and 50mg Miltefosine (Impavido®) | Drug: Miltefosine<br>* Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.<br>* Other names: Miltefosine cap 10mg and 50mg, Impavido® (Zentaris);|
| Active Comparator: Group 2<br>Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days. | Drug: Meglumine antimoniate<br>* Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.<br>* Other names: Glucantime® of Aventis: Amp of 5ml (83mg/ml).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with parasitologic response 26 weeks after the initiation of treatment. |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cutaneous Leishmaniasis, Leishmania Viannia, Pediatric, Miltefosine, Randomized, Colombia