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NCT00233545 Clinical Trial

Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

Cutaneous Leishmaniasis Clinical Trial

Official title:
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00233545
Other study ID # 01-2005
Secondary ID
Status Completed
Phase Phase 2
First received September 28, 2005
Last updated May 29, 2010
Start date September 2005
Est. completion date September 2007

Study information
Verified date May 2010
Source AB Foundation
Contact n/a
Is FDA regulated No
Health authority Bolivia: Ethics Committee
Study type Interventional

Clinical Trial 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• miltefosine

• antimony

Locations
Country Name City State
Bolivia Puesto de Salud, Campamento OSCAR, Palos Blancos,

Sponsors (1)
Lead Sponsor Collaborator
AB Foundation

Country where clinical trial is conducted

Bolivia, 

Outcome
Type Measure Description Time frame Safety issue
Primary cure rate
See also
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Terminated NCT00317629 - Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Phase 3
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Completed NCT01050777 - Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis Phase 0
Completed NCT01380314 - Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis Phase 2
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Completed NCT03023111 - Miltefosine and GM-CSF in Cutaneous Leishmaniasis Phase 3