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Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

Primary Purpose

Cutaneous Leishmaniasis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Miltefosine
Meglumine antimoniate
Sponsored by
Centro Internacional de Entrenamiento e Investigaciones Médicas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Leishmaniasis focused on measuring Cutaneous Leishmaniasis, Leishmania Viannia, Pediatric, Miltefosine, Randomized, Colombia

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days. presentation: capsulas 10mg and 50mg Miltefosine (Impavido®)

    Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days.

    Outcomes

    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.
    Evidence of clinical or laboratory toxicity during the treatment period.

    Secondary Outcome Measures

    Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment.

    Full Information

    First Posted
    June 14, 2007
    Last Updated
    February 13, 2010
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00487253
    Brief Title
    Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    December 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the 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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cutaneous Leishmaniasis
    Keywords
    Cutaneous Leishmaniasis, Leishmania Viannia, Pediatric, Miltefosine, Randomized, Colombia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days. presentation: capsulas 10mg and 50mg Miltefosine (Impavido®)
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Miltefosine
    Other Intervention Name(s)
    Miltefosine cap 10mg and 50mg, Impavido® (Zentaris)
    Intervention Description
    Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Meglumine antimoniate
    Other Intervention Name(s)
    Glucantime® of Aventis: Amp of 5ml (83mg/ml).
    Intervention Description
    Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.
    Primary Outcome Measure Information:
    Title
    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)
    Title
    Evidence of clinical or laboratory toxicity during the treatment period.
    Time Frame
    During the treatment period (20 or 28 days)
    Secondary Outcome Measure Information:
    Title
    Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment.
    Time Frame
    26 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luisa Consuelo Rubiano, MD, MSc
    Organizational Affiliation
    Centro Internacional de Entrenamiento e Investigaciones Médicas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28379954
    Citation
    Castro MDM, Cossio A, Velasco C, Osorio L. Risk factors for therapeutic failure to meglumine antimoniate and miltefosine in adults and children with cutaneous leishmaniasis in Colombia: A cohort study. PLoS Negl Trop Dis. 2017 Apr 5;11(4):e0005515. doi: 10.1371/journal.pntd.0005515. eCollection 2017 Apr.
    Results Reference
    derived
    PubMed Identifier
    22238470
    Citation
    Rubiano LC, Miranda MC, Muvdi Arenas S, Montero LM, Rodriguez-Barraquer I, Garcerant D, Prager M, Osorio L, Rojas MX, Perez 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.
    Results Reference
    derived

    Learn more about this trial

    Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

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