NCT01953744

High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

Phase 3 Randomized Trial Comparing Fluconazole to Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by L. Braziliensis and L. Guyanensis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Hospital Universitário Professor Edgard Santos · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the therapeutic response to fluconazole in patients with cutaneous leishmaniasis caused by and L.(V.)guyanensis and L.(V.) braziliensis.

Conditions

• Cutaneous Leishmaniasis

Interventions

Type	Name	Description
DRUG	Fluconazole	Fluconazole is presented in 150mg capsules and will be administered by oral route at a dosage of 6-8mg/kg/day during 28 days.
DRUG	Meglumine Antimoniate	Meglumine Antimoniate will be administered as the standard treatment for cutaneous leishmaniasis by intravenous route at a dosage of 20mg/kg/day, during 20 days.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-04-01
• Completion: 2015-11-01
• First posted: 2013-10-01
• Last updated: 2015-12-02

Locations

1 site across 1 country: Brazil