Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

This study is currently recruiting participants.

Verified by Centro Internacional de Entrenamiento e Investigaciones Médicas, July 2007

First Received: June 14, 2007 Last Updated: July 26, 2007 History of Changes

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
Information provided by:	Centro Internacional de Entrenamiento e Investigaciones Médicas
ClinicalTrials.gov Identifier:	NCT00487253

Purpose

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.

Condition	Intervention	Phase
Cutaneous Leishmaniasis	Drug: miltefosine Drug: meglumine antimoniate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis

Drug Information available for: Miltefosine Glucantime Meglumine

U.S. FDA Resources

Further study details as provided by Centro Internacional de Entrenamiento e Investigaciones Médicas:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	150
Study Start Date:	July 2007

Eligibility

Ages Eligible for Study:	2 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487253

Contacts

Contact: Maria Consuelo Miranda, MD, MSc	(571)6682164 ext 216	clinico@cideim.org.co
Contact: Isabel Rodriguez, MD	(571)6682164 ext 307	irodriguez@cideim.org.co

Locations

Colombia, Valle del Cauca
CIDEIM	Recruiting
Cali, Valle del Cauca, Colombia
Contact: Maria Consuelo Miranda, MD, MSc (571) 6682164 clinico@cideim.org.co

Sponsors and Collaborators

Centro Internacional de Entrenamiento e Investigaciones Médicas

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:

Maria Consuelo Miranda, MD, MSc

Centro Internacional de Entrenamiento e Investigaciones Médicas

More Information

No publications provided

Study ID Numbers:	50100119
Study First Received:	June 14, 2007
Last Updated:	July 26, 2007
ClinicalTrials.gov Identifier:	NCT00487253 History of Changes
Health Authority:	Colombia: Institutional Review Board

Keywords provided by Centro Internacional de Entrenamiento e Investigaciones Médicas:

Cutaneous Leishmaniasis
Leishmania Viannia
Pediatric

Miltefosine
Randomized
Colombia

Additional relevant MeSH terms:

Leishmaniasis
Anti-Infective Agents
Protozoan Infections
Antiprotozoal Agents
Skin Diseases, Parasitic
Skin Diseases
Antineoplastic Agents
Miltefosine
Meglumine antimoniate

Mastigophora Infections
Leishmaniasis, Cutaneous
Pharmacologic Actions
Skin Diseases, Infectious
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Sarcomastigophora Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on November 30, 2009