NCT00818818

Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients

Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients Infected With Leishmania (Viannia) Braziliensis in Bahia State, Brazil. An Open Uncontrolled Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Brasilia · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.

Conditions

• Localized Cutaneous Leishmaniasis

Interventions

Type	Name	Description
DRUG	Meglumine antimoniate	5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2009-01-08
• Last updated: 2010-10-08

Locations

1 site across 1 country: Brazil