Prevention of invasive fungal infection in high risk patients following liver transplant.
After receiving liver transplant, subjects will be randomized to one of the two treatment arms. Study drugs will be administered for a period of 21 days, or until hospital discharge, whichever occurs first. Additionally, mortality data will be collected at the Long-term Follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
350
Unnamed facility
Innsbruck, Austria
'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).
Time frame: up to 21 days
Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB
Time frame: 3 months
Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator
Time frame: up to 21 days & 3 months
Time to 'proven' or 'probable' IFD
Time frame: up to 3 months
Fungal free survival at the End of Study and at the end of Long-term Follow-up
Time frame: 3 months & 6 months
Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline
Time frame: up to 21 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
intravenous infusion
Unnamed facility
Antwerp, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Ghent, Belgium
Unnamed facility
Paris, Villejuif Cedex, France
Unnamed facility
Clichy, France
Unnamed facility
Paris, France
Unnamed facility
Toulouse, France
Unnamed facility
Berlin, Germany
...and 26 more locations