Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

February 13, 2010 updated by: Centro Internacional de Entrenamiento e Investigaciones Médicas

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1

Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days.

presentation: capsulas 10mg and 50mg Miltefosine (Impavido®)
Drug: Miltefosine
Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.
Other Names:
  • Miltefosine cap 10mg and 50mg, Impavido® (Zentaris)
ACTIVE_COMPARATOR: Group 2
Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days.
Drug: Meglumine antimoniate
Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.
Other Names:
  • Glucantime® of Aventis: Amp of 5ml (83mg/ml).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 26 weeks (6 months)
26 weeks (6 months)
Evidence of clinical or laboratory toxicity during the treatment period.
Time Frame: During the treatment period (20 or 28 days)
During the treatment period (20 or 28 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment.
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Internacional de Entrenamiento e Investigaciones Médicas

Collaborators

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
INS
Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta

Investigators

  • Principal Investigator: Luisa Consuelo Rubiano, MD, MSc, Centro Internacional de Entrenamiento e Investigaciones Médicas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

June 14, 2007

First Submitted That Met QC Criteria

June 15, 2007

First Posted (ESTIMATE)

June 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 17, 2010

Last Update Submitted That Met QC Criteria

February 13, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50100119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cutaneous Leishmaniasis

Clinical Trials on Miltefosine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe