Prophylaxis With Caspofungin in High-Risk Liver Transplantation
Status:
Unknown status
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
Summary
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%.