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Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00233545
First Posted: October 6, 2005
Last Update Posted: June 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AB Foundation
  Purpose
Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L braziliensis in Bolivia and cutaneous leishmaniasis due to L panamensis in Colombia. This trial is intended to evaluate miltefosine for cutaneous leishmaniasis due to L braziliensis in Bolivia. Patients will be randomly assigned to miltefosine or pentavalent antimony. Standard dose regimens will be used for both drugs.

Condition Intervention Phase
Cutaneous Leishmaniasis Drug: miltefosine Drug: antimony Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

Resource links provided by NLM:


Further study details as provided by AB Foundation:

Primary Outcome Measures:
  • cure rate

Estimated Enrollment: 80
Study Start Date: September 2005
Estimated Study Completion Date: September 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Presentation: At least 1 lesion must be ulcerative. Parasitology: Parasitological confirmation of 1 lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion.

Previous RX: No specific or putatively specific therapy for leishmaniasis (Sb, pentamidine, amphotericin B, imidazoles, allopurinol)

Other diseases: No concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (SGOT) and kidney function tests (creatinine).

  Contacts and Locations
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): NCT00233545


Locations
Bolivia
Puesto de Salud, Campamento OSCAR,
Palos Blancos,, Bolivia
Sponsors and Collaborators
AB Foundation
Investigators
Principal Investigator: J Soto, MD FADER
  More Information

ClinicalTrials.gov Identifier: NCT00233545     History of Changes
Other Study ID Numbers: 01-2005
First Submitted: September 28, 2005
First Posted: October 6, 2005
Last Update Posted: June 2, 2010
Last Verified: May 2010

Keywords provided by AB Foundation:
cutaneous
leishmaniasis
drug
miltefosine

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
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