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Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis

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. Identifier: NCT00373568
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : June 2, 2010
Information provided by:
AB Foundation

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

Condition or disease Intervention/treatment Phase
Leishmaniasis Drug: miltefosine: 2.5 mg/kg/day for 42 days Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Miltefosine (42 Days) for Mucosal Leishmaniasisi
Study Start Date : April 2005
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Miltefosine

Primary Outcome Measures :
  1. efficacy

Secondary Outcome Measures :
  1. safety

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Mucosal leishmaniasis

Exclusion Criteria:

  • No comcomitant disease as judged by laboratory and clinical parameters

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 identifier (NCT number): NCT00373568

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

Layout table for additonal information Identifier: NCT00373568     History of Changes
Other Study ID Numbers: 05--01
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: June 2, 2010
Last Verified: May 2010
Keywords provided by AB Foundation:
Additional relevant MeSH terms:
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Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents