Back to resultsMiltefosine (Long Course) for Bolivian Mucosal Leishmaniasis
Primary Purpose
Leishmaniasis
Status
Completed
Phase
Phase 1
Locations
Bolivia
Study Type
Interventional
Intervention
miltefosine: 2.5 mg/kg/day for 42 days
Sponsored by
About this trial
This is an interventional treatment trial for Leishmaniasis focused on measuring mucosal, miltefosine
Eligibility Criteria
Inclusion Criteria:
- Mucosal leishmaniasis
Exclusion Criteria:
- No comcomitant disease as judged by laboratory and clinical parameters
Sites / Locations
- Palos Blancos
Outcomes
Primary Outcome Measures
efficacy
Secondary Outcome Measures
safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00373568
Brief Title
Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis
Official Title
Miltefosine (42 Days) for Mucosal Leishmaniasisi
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AB Foundation
4. Oversight
5. Study Description
Brief Summary
Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis
Detailed Description
Miltefosine (42 days) will be used to try to improve upon the cure rate with 28 days of drug for bolivian mucosal leishmaniasisi
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis
Keywords
mucosal, miltefosine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
miltefosine: 2.5 mg/kg/day for 42 days
Primary Outcome Measure Information:
Title
efficacy
Secondary Outcome Measure Information:
Title
safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mucosal leishmaniasis
Exclusion Criteria:
No comcomitant disease as judged by laboratory and clinical parameters
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Soto, MD
Organizational Affiliation
CIBIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palos Blancos
City
Palos Blancos
Country
Bolivia
12. IPD Sharing Statement
Learn more about this trial
Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis
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