Cutaneous Leishmaniasis Clinical Trial
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
Verified date | February 2010 |
Source | Centro Internacional de Entrenamiento e Investigaciones Médicas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Unknown status |
Enrollment | 150 |
Est. completion date | December 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 12 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centro Internacional de Entrenamiento e Investigaciones Médicas | INS, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | ||
Primary | Evidence of clinical or laboratory toxicity during the treatment period. | During the treatment period (20 or 28 days) | ||
Secondary | Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment. | 26 weeks |
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