Back to resultsMiltefosine to Treat Cutaneous Leishmaniasis in Bolivia
Primary Purpose
Cutaneous Leishmaniasis
Status
Completed
Phase
Phase 2
Locations
Bolivia
Study Type
Interventional
Intervention
miltefosine
antimony
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Leishmaniasis focused on measuring cutaneous, leishmaniasis, drug, miltefosine
Eligibility Criteria
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. Previous RX: No specific or putatively specific therapy for leishmaniasis (Sb, pentamidine, amphotericin B, imidazoles, allopurinol) Other diseases: No concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (SGOT) and kidney function tests (creatinine).
Sites / Locations
- Puesto de Salud, Campamento OSCAR,
Outcomes
Primary Outcome Measures
cure rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233545
Brief Title
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia
Official Title
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AB Foundation
4. Oversight
5. Study Description
Brief Summary
Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L braziliensis in Bolivia and cutaneous leishmaniasis due to L panamensis in Colombia. This trial is intended to evaluate miltefosine for cutaneous leishmaniasis due to L braziliensis in Bolivia. Patients will be randomly assigned to miltefosine or pentavalent antimony. Standard dose regimens will be used for both drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Leishmaniasis
Keywords
cutaneous, leishmaniasis, drug, miltefosine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
miltefosine
Intervention Type
Drug
Intervention Name(s)
antimony
Primary Outcome Measure Information:
Title
cure rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Previous RX: No specific or putatively specific therapy for leishmaniasis (Sb, pentamidine, amphotericin B, imidazoles, allopurinol)
Other diseases: No concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (SGOT) and kidney function tests (creatinine).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Soto, MD
Organizational Affiliation
FADER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Puesto de Salud, Campamento OSCAR,
City
Palos Blancos,
Country
Bolivia
12. IPD Sharing Statement
Learn more about this trial
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia
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