NCT00537953

Brief Summary

The combination of a half-course of miltefosine and a half-course of antimony will be evaluated for efficacy and tolerance. The combination of miltefosine and antimony is chosen because these are now the two standard agents in Bolivia, and in vitro the combination was additive to mildly synergistic against a standard leishmania strain.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
Last Updated

October 2, 2007

Status Verified

September 1, 2007

First QC Date

September 28, 2007

Last Update Submit

September 28, 2007

Conditions

Cutaneous Leihmaniasis

Keywords

LeishmaniasisCutaneous leishmaniasisMiltefosineGlucantimeAntimonyPentavalent antimonialsCombination therapy

Interventions

Miltefosine , meglumine antimoniateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gender: Male Age: Adults Presentation: At least 1 lesion must be ulcerative. Parasitology: Parasitological confirmation of 1 lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion.

You may not qualify if:

  • Previous treatment for leishmaniasis, specific or putatively specific therapy (Sb, pentamidine, amphotericin B, imidazoles, allopurinol)
  • Other concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (SGOT), values of pancreatic function (lipase), kidney function tests (creatinine), and EKG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Dermatológico

Jorochito, Santa Cruz Department, 00000, Bolivia

RECRUITING

MeSH Terms

Conditions

LeishmaniasisLeishmaniasis, Cutaneous

Interventions

miltefosineMeglumine Antimoniate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MeglumineSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsHexosaminesAmino SugarsCarbohydrates

Study Officials

  • Jonathan Berman, MD, PhD

    AB Foundation for Medical Research

    STUDY CHAIR

  • Jorge Vargas, MD

    Cenetrop

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime Soto, MD

CONTACT

571 348 2171j.soto@medplus.org.co

Julia Toledo, MD

CONTACT

571 347 6093toledo_julia@yahoo.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2007

First Posted

October 2, 2007

Last Updated

October 2, 2007

Record last verified: 2007-09

Locations

BO(1)