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| Sponsored by: |
AB Foundation |
| Information provided by: | AB Foundation |
| ClinicalTrials.gov Identifier: | NCT00233545 |
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 |
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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 |
Eligibility
| 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).
Contacts and Locations More Information
| 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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