Overview

This trial is active, not recruiting.

Condition cutaneous leishmaniasis
Treatments miltefosine, meglumine antimoniate
Phase phase 3
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days. presentation: capsulas 10mg and 50mg Miltefosine (Impavido®)
miltefosine Miltefosine cap 10mg and 50mg, Impavido® (Zentaris)
Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.
(Active Comparator)
Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days.
meglumine antimoniate Glucantime® of Aventis: Amp of 5ml (83mg/ml).
Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.

Primary Outcomes

Measure
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

Measure
Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment.
time frame: 26 weeks

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Centro Internacional de Entrenamiento e Investigaciones Médicas.