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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

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
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

MedlinePlus related topics:   Leishmaniasis   

ChemIDplus related topics:   Miltefosine    Glucantime    Meglumine   

U.S. FDA Resources

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

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

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

Keywords provided by Centro Internacional de Entrenamiento e Investigaciones Médicas:
Cutaneous Leishmaniasis  
Leishmania Viannia  
Pediatric  
Miltefosine
Randomized
Colombia

Study placed in the following topic categories:
Leishmaniasis
Protozoan Infections
Skin Diseases, Infectious
Skin Diseases
Clotrimazole
Miconazole
Miltefosine
Meglumine antimoniate
Tioconazole
Parasitic Diseases
Leishmaniasis, Cutaneous

Additional relevant MeSH terms:
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Skin Diseases, Parasitic
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses
Sarcomastigophora Infections
Mastigophora Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008




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