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Sponsored by: |
AB Foundation |
Information provided by: | AB Foundation |
ClinicalTrials.gov Identifier: | NCT00233545 |
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 II |
MedlinePlus related topics: | Leishmaniasis |
ChemIDplus related topics: | Miltefosine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia |
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).
Study ID Numbers: | 01-2005 |
First Received: | September 28, 2005 |
Last Updated: | September 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00233545 |
Health Authority: | Bolivia: Ethics Committee |
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