Status:
COMPLETED
Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis
Lead Sponsor:
University of Brasilia
Collaborating Sponsors:
Ministry of Health, Brazil
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
7-50 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will...
Detailed Description
The first-choice drug for the treatment of cutaneous leishmaniasis in Brazil is the pentavalent antimonial meglumine antimoniate. The treatment with meglumine antimoniate is toxic and at least some of...
Eligibility Criteria
Inclusion
- Presence of 1 to 9 cutaneous lesions clinically compatible with leishmaniasis
- Disease duration of 2 to 20 weeks
- Positive leishmanin skin test
- Parasitological diagnosis confirmed through culture or genus-specific polymerase chain reaction (PCR) for Leishmania spp
Exclusion
- History of past episode of leishmaniasis
- Mucosal disease
- Disseminated disease
- Use of drugs with anti-leishmanial activity
- Contraindications for using pentavalent antimony:
- pregnancy
- renal failure
- heart failure
- hepatic failure
- Other diseases:
- active tuberculosis
- hanseniasis
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00317980
Start Date
February 1 2006
End Date
December 1 2008
Last Update
January 22 2009
Active Locations (1)
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1
Núcleo de Medicina Tropical, University of Brasilia
Brasília, Federal District, Brazil, 70904-970