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
Sponsor:
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
First received: June 14, 2007
Last updated: February 13, 2010
Last verified: February 2010

June 14, 2007
February 13, 2010
July 2007
February 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • 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) ]
Complete list of historical versions of study NCT00487253 on ClinicalTrials.gov Archive Site
Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment. [ Time Frame: 26 weeks ]
Not Provided
Not Provided
 
Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cutaneous Leishmaniasis
  • Drug: Miltefosine
    Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.
    Other Name: Miltefosine cap 10mg and 50mg, Impavido® (Zentaris)
  • 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).
  • 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®)

    Intervention: Drug: Miltefosine
  • Active Comparator: Group 2
    Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days.
    Intervention: Drug: Meglumine antimoniate
Rubiano LC, Miranda MC, Muvdi Arenas S, Montero LM, Rodríguez-Barraquer I, Garcerant D, Prager M, Osorio L, Rojas MX, Pérez M, Nicholls RS, Gore Saravia N. Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children. J Infect Dis. 2012 Feb 15;205(4):684-92. doi: 10.1093/infdis/jir816. Epub 2012 Jan 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
December 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
2 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00487253
50100119
Yes
Santiago Nicholls, Instituto Nacional de Salud
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
Principal Investigator: Luisa Consuelo Rubiano, MD, MSc Centro Internacional de Entrenamiento e Investigaciones Médicas
Centro Internacional de Entrenamiento e Investigaciones Médicas
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP