NCT01303549

Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients

Multicenter, Randomized, Open-label Clinical Trial to Compare Anidulafungin Versus Amphotericin B Safety in High Risk Hepatic Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Fundacion SEIMC-GESIDA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a randomized, open-label safety study comparing the use of anidulafungin (200 mg i.v. as initial dose and 100 mg/d i.v. in subsequent doses) vs liposomal amphotericin B (3 mg/kg/d i.v.) in hepatic transplant recipients who have high risk of fungal infection.

Conditions

• Liver Disease
• Fungal Infection

Interventions

Type	Name	Description
DRUG	Anidulafungin	Anidulafungin once a day for 14 days: initial dose 200 mg/day IV administered in 180 minutes. Following doses 100 mg/day IV administered in 90 minutes.
DRUG	Liposomal amphotericin B	Liposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-02-24
• Last updated: 2014-05-30

Locations

12 sites across 1 country: Spain