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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
History of Changes
  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:

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

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
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
Leishmaniasis, Mucocutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Leishmaniasis, Cutaneous
 Miltefosine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents

ClinicalTrials.gov processed this record on May 16, 2013