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Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis

This study has been completed.
Information provided by:
AB Foundation Identifier:
First received: September 7, 2006
Last updated: May 29, 2010
Last verified: May 2010
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

Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00373568

Palos Blancos
Palos Blancos, Bolivia
Sponsors and Collaborators
AB Foundation
Principal Investigator: Jaime Soto, MD CIBIC
  More Information Identifier: NCT00373568     History of Changes
Other Study ID Numbers: 05--01
Study First Received: September 7, 2006
Last Updated: May 29, 2010

Keywords provided by AB Foundation:

Additional relevant MeSH terms:
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 processed this record on September 21, 2017