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Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

This study has been completed.
Sponsor:
Information provided by:
AB Foundation
ClinicalTrials.gov Identifier:
NCT00233545
First received: September 28, 2005
Last updated: May 29, 2010
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

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

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00233545     History of Changes
Other Study ID Numbers: 01-2005
Study First Received: September 28, 2005
Last Updated: May 29, 2010
Health Authority: Bolivia: Ethics Committee

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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents

ClinicalTrials.gov processed this record on June 17, 2013