NCT00487253

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2007

Typical duration for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2007

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

Enrollment Period

2.6 years

First QC Date

June 14, 2007

Last Update Submit

February 13, 2010

Conditions

Cutaneous Leishmaniasis

Keywords

Cutaneous LeishmaniasisLeishmania VianniaPediatricMiltefosineRandomizedColombia

Outcome Measures

Primary Outcomes (2)

  • 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.

    26 weeks (6 months)

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

    During the treatment period (20 or 28 days)

Secondary Outcomes (1)

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

    26 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Drug: Miltefosine

Group 2

ACTIVE COMPARATOR

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

Drug: Meglumine antimoniate

Interventions

MiltefosineDRUG

Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.

Also known as: Miltefosine cap 10mg and 50mg, Impavido® (Zentaris)
Group 1
Meglumine antimoniateDRUG

Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.

Also known as: Glucantime® of Aventis: Amp of 5ml (83mg/ml).
Group 2

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 28379954DERIVED

  • 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.

    PMID: 22238470DERIVED

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

miltefosineMeglumine Antimoniate

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MeglumineSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsHexosaminesAmino SugarsCarbohydrates

Study Officials

  • Luisa Consuelo Rubiano, MD, MSc

    Centro Internacional de Entrenamiento e Investigaciones Médicas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2007

First Posted

June 18, 2007

Study Start

July 1, 2007

Primary Completion

February 1, 2010

Study Completion

December 1, 2010

Last Updated

February 17, 2010

Record last verified: 2010-02