This is a non-comparative, open, multisite prospective estimation study to evaluate the efficacy and safety of caspofungin in the prophylactic treatment of adults who have received an orthotopic liver transplant and are at high risk of developing an invasive fungal infection. It is expected that the proportion of high-risk liver transplant recipients who develop a documented (proven or probable per European Organization for Research and Treatment of Cancer/Mycoses Study Group \[EORTC/MSG\] modified criteria) invasive fungal infection during the first 100 days after the onset of prophylaxis with caspofungin will be lower than 15%. It is also expected that the incidence of serious drug-related adverse events will be less than 25%.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
70
Complejo Hospitalario Juan Canalejo
A Coruña, Spain
RECRUITINGHospital de Cruces
Barakaldo, Spain
RECRUITINGHospital Universitari Vall d'Hebron
Barcelona, Spain
RECRUITINGComplejo Hospitalario Reina Sofia
Córdoba, Spain
WITHDRAWNHospital Universitario Virgen de las Nieves
Granada, Spain
RECRUITINGHospital General Universitario Gregorio Marañón
Madrid, Spain
RECRUITINGHospital Ramon y Cajal
Madrid, Spain
RECRUITINGHospital Universitario Puerta de Hierro
Madrid, Spain
RECRUITINGHospital 12 de Octubre
Madrid, Spain
RECRUITINGComplejo Hospitalario Carlos Haya
Málaga, Spain
RECRUITING...and 3 more locations
Absence of breakthrough proven/probable invasive fungal infection by day +100
Absence of breakthrough proven/probable invasive aspergillosis by day +100
Discontinuation of study therapy due to a drug-related adverse event
Incidence of drug-related serious adverse event(s)
Incidence of drug-related adverse event(s)
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