Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

This study has been completed.
Information provided by:
AB Foundation Identifier:
First received: September 28, 2005
Last updated: May 29, 2010
Last verified: May 2010

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:

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

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).

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Please refer to this study by its identifier: NCT00233545

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

No publications provided 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:

Additional relevant MeSH terms:
Leishmaniasis, Cutaneous
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic
Anti-Infective Agents
Antifungal Agents
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 13, 2015