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Miltefosine for Mucosal Leishmaniasis

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ClinicalTrials.gov Identifier: NCT00373776
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : September 8, 2006
Sponsor:
Information provided by:
AB Foundation

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This trial will study miltefosine as a treatment for mucosal leishmaniasis.

Condition or disease Intervention/treatment Phase
Leishmaniasis Drug: miltefosine 2.5 mg/kg/day for 28 days Phase 1 Phase 2

Detailed Description:
Treat bolivian mucosal leishmaniasis with miltefosine.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2004
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Miltefosine
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Efficacy

Secondary Outcome Measures :
  1. toxicity

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mucosal leishmaniasis

Exclusion Criteria:

  • Abnormal liver function tests (LFT)
  • Abnormal kidney function test
  • Concomitant diseases
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373776


Locations
Bolivia
Palos Blancos, Bolivia
Sponsors and Collaborators
AB Foundation
Investigators
Principal Investigator: Jaime soto, MD CIBIC
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00373776     History of Changes
Other Study ID Numbers: 04--01
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: September 2006

Keywords provided by AB Foundation:
mucosal
leishmaniasis
miltefosine

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