Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
This trial is active, not recruiting.
|Treatments||miltefosine, meglumine antimoniate|
|Sponsor||Centro Internacional de Entrenamiento e Investigaciones Médicas|
|Collaborator||Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)|
|Start date||July 2007|
|End date||February 2010|
|Trial size||150 participants|
|Trial identifier||NCT00487253, 50100119|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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)
Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment.
time frame: 26 weeks
Male or female participants from 2 years up to 12 years old.
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
|Official title||Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia|
|Principal investigator||Luisa Consuelo Rubiano, MD, MSc|
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