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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
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.
Liposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes.
Hospital Reina Sofia
Córdoba, Córdoba, Spain
Complexo Hospitalario de A Coruña
A Coruña, Spain
Hospital Clinic i Provincial
Barcelona, Spain
Hospital de Bellvitge
Renal impairment/renal function deterioration
Compare the development of renal imparment or deterioration of baseline renal function in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B
Time frame: 14 days
Number of infusion related adverse events
Compare the development of infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B
Time frame: 14 days
Treatment discontinuation
Compare the proportion of patiens who discontinue antifungal profilaxis in both arms
Time frame: 14 days
Hepatic toxicity
Compare the emergence of hepatic toxicity in both arms
Time frame: 14 days
Invasive fungal infection
Compare the incidence of early (first 12 weeks) and delayed (until week 24) invasive fungal infection between both arms
Time frame: Week 12 and week 24
Mortality
Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation
Time frame: 24 weeks post transplantation
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Barcelona, Spain
Hospital Vall d'Hebrón
Barcelona, Spain
Hospital de Cruces
Bilbao, Spain
Hospital Doce de Octubre
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Carlos Haya
Málaga, Spain
...and 2 more locations