Status:
COMPLETED
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia
Lead Sponsor:
AB Foundation
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
3+ years
Phase:
PHASE2
Brief Summary
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 Bolivi...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00233545
Start Date
September 1 2005
End Date
September 1 2007
Last Update
June 2 2010
Active Locations (1)
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1
Puesto de Salud, Campamento OSCAR,
Palos Blancos, Bolivia