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Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373568
First Posted: September 8, 2006
Last Update Posted: June 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AB Foundation
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Miltefosine (42 Days) for Mucosal Leishmaniasisi

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mucosal leishmaniasis

Exclusion Criteria:

  • No comcomitant disease as judged by laboratory and clinical parameters
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373568


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

ClinicalTrials.gov Identifier: NCT00373568     History of Changes
Other Study ID Numbers: 05--01
First Submitted: September 7, 2006
First Posted: September 8, 2006
Last Update Posted: June 2, 2010
Last Verified: May 2010

Keywords provided by AB Foundation:
mucosal
miltefosine

Additional relevant MeSH terms:
Leishmaniasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Miltefosine
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents