Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 be done in a field clinic in the state of Bahia, Brazil.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Brasilia
• Collaborator: Ministry of Health, Brazil
• Treatments: Meglumine Antimoniate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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