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Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis

This study has been completed.
Sponsor:
Information provided by:
AB Foundation
ClinicalTrials.gov Identifier:
NCT00373568
First received: September 7, 2006
Last updated: May 29, 2010
Last verified: May 2010
  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
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

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00373568

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

No publications provided

ClinicalTrials.gov 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:
mucosal
miltefosine

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

ClinicalTrials.gov processed this record on November 23, 2014