MedTrace Logo

Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

NCT00487253 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2010-02-17

No results posted yet for this study

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.

Conditions

  • Cutaneous Leishmaniasis

Interventions

DRUG

Miltefosine

Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.

DRUG

Meglumine antimoniate

Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.

Sponsors & Collaborators

  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

    collaborator OTHER_GOV

  • INS

    collaborator UNKNOWN

  • Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta

    collaborator UNKNOWN

  • Centro Internacional de Entrenamiento e Investigaciones Médicas

    lead OTHER

Principal Investigators

  • Luisa Consuelo Rubiano, MD, MSc · Centro Internacional de Entrenamiento e Investigaciones Médicas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-02-28
Completion
2010-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00487253 on ClinicalTrials.gov