Miltefosine for Mucosal Leishmaniasis

This study has been completed.
Information provided by:
AB Foundation Identifier:
First received: September 7, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
This trial will study miltefosine as a treatment for mucosal leishmaniasis.

Condition Intervention Phase
Drug: miltefosine 2.5 mg/kg/day for 28 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

Resource links provided by NLM:

Further study details as provided by AB Foundation:

Primary Outcome Measures:
  • Efficacy

Secondary Outcome Measures:
  • toxicity

Estimated Enrollment: 75
Study Start Date: April 2004
Estimated Study Completion Date: May 2006
Detailed Description:
Treat bolivian mucosal leishmaniasis with miltefosine.

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mucosal leishmaniasis

Exclusion Criteria:

  • Abnormal liver function tests (LFT)
  • Abnormal kidney function test
  • Concomitant diseases
  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: NCT00373776

Palos Blancos, Bolivia
Sponsors and Collaborators
AB Foundation
Principal Investigator: Jaime soto, MD CIBIC
  More Information Identifier: NCT00373776     History of Changes
Other Study ID Numbers: 04--01 
Study First Received: September 7, 2006
Last Updated: September 7, 2006
Health Authority: Bolivia: Ethics Committee

Keywords provided by AB Foundation:

Additional relevant MeSH terms:
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic
Anti-Infective Agents
Antifungal Agents
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents processed this record on May 30, 2016