Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by Centro Internacional de Entrenamiento e Investigaciones Médicas. Recruitment status was Active, not recruiting

First Received on June 14, 2007. Last Updated on February 13, 2010 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: Tisocromide 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) ] [ Designated as safety issue: Yes ]
Evidence of clinical or laboratory toxicity during the treatment period. [ Time Frame: During the treatment period (20 or 28 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: Glucantime® of Aventis: Amp of 5ml (83mg/ml).

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

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:

Luisa Consuelo Rubiano, MD, MSc

Centro Internacional de Entrenamiento e Investigaciones Médicas

More Information

No publications provided

Responsible Party:	Santiago Nicholls, Instituto Nacional de Salud
ClinicalTrials.gov Identifier:	NCT00487253 History of Changes
Other Study ID Numbers:	50100119
Study First Received:	June 14, 2007
Last Updated:	February 13, 2010
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
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine antimoniate

Miltefosine
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on February 12, 2012