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Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis
This study is ongoing, but not recruiting participants.
Sponsored by: AB Foundation
Information provided by: AB Foundation
ClinicalTrials.gov Identifier: NCT00373568
  Purpose

Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis


Condition Intervention Phase
Leishmaniasis
Drug: miltefosine: 2.5 mg/kg/day for 42 days
Phase I
Phase II

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Miltefosine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Miltefosine (42 Days) for Mucosal Leishmaniasisi

Further study details as provided by AB Foundation:

Primary Outcome Measures:
  • efficacy

Secondary Outcome Measures:
  • safety

Estimated Enrollment: 25
Study Start Date: April 2005
Estimated Study Completion Date: December 2007
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

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mucosal leishmaniasis

Exclusion Criteria:

  • No comcomitant disease as judged by laboratory and clinical parameters
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373568

Locations
Bolivia
Palos Blancos
palos blancos, Bolivia
Sponsors and Collaborators
AB Foundation
Investigators
Principal Investigator: Jaime Soto, MD CIBIC
  More Information

Study ID Numbers: 05--01
Study First Received: September 7, 2006
Last Updated: September 7, 2006
ClinicalTrials.gov Identifier: NCT00373568  
Health Authority: Bolivia: Ethics Committee

Keywords provided by AB Foundation:
mucosal
miltefosine

Study placed in the following topic categories:
Leishmaniasis, Mucocutaneous
Leishmaniasis
Protozoan Infections
Skin Diseases, Infectious
Skin Diseases
Clotrimazole
Miconazole
Miltefosine
Tioconazole
Parasitic Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Skin Diseases, Parasitic
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses
Sarcomastigophora Infections
Mastigophora Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009