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Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

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ClinicalTrials.gov Identifier: NCT00487253
Recruitment Status : Unknown
Verified February 2010 by Centro Internacional de Entrenamiento e Investigaciones Médicas.
Recruitment status was:  Active, not recruiting
First Posted : June 18, 2007
Last Update Posted : February 17, 2010
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Drug: Miltefosine Drug: Meglumine antimoniate Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2007
Primary Completion Date : February 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

Arms and Interventions

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 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).

Outcome Measures

Primary Outcome Measures :
  1. 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) ]
  2. Evidence of clinical or laboratory toxicity during the treatment period. [ Time Frame: During the treatment period (20 or 28 days) ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487253

Sponsors and Collaborators
Centro Internacional de Entrenamiento e Investigaciones Médicas
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta
Principal Investigator: Luisa Consuelo Rubiano, MD, MSc Centro Internacional de Entrenamiento e Investigaciones Médicas
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Santiago Nicholls, Instituto Nacional de Salud
ClinicalTrials.gov Identifier: NCT00487253     History of Changes
Other Study ID Numbers: 50100119
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: February 2010

Keywords provided by Centro Internacional de Entrenamiento e Investigaciones Médicas:
Cutaneous Leishmaniasis
Leishmania Viannia

Additional relevant MeSH terms:
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine antimoniate
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents