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
Drug: miltefosine: 2.5 mg/kg/day for 42 days
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00373568

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

No publications provided Identifier: NCT00373568     History of Changes
Other Study ID Numbers: 05--01
Study First Received: September 7, 2006
Last Updated: May 29, 2010
Health Authority: Bolivia: Ethics Committee

Keywords provided by AB Foundation:

Additional relevant MeSH terms:
Leishmaniasis, Mucocutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Leishmaniasis, Cutaneous
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents processed this record on April 16, 2014