Fungal Infection, Liver Transplantation
Conditions
Keywords
Liver transplantation, Invasive fungal infection, Invasive aspergillosis, Prophylaxis, Caspofungin
Brief 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%.
Interventions
DRUGCaspofungin
Sponsors
Merck Sharp & Dohme LLC
Grupo de Estudio de Infecciones en Transplantados
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Patient has received an orthotopic liver transplantation * Patient meets criteria, as defined per protocol, for being considered at high risk of developing an invasive fungal infection post-liver transplantation * For women of childbearing potential, patient must have a negative serum or urine pregnancy test
Exclusion criteria
* Any systemic antifungal therapy (other than fluconazole for a maximum of 7 days) within 14 days of the administration of the study drug. * Documented (proven/probable) or suspected (possible) invasive fungal infection at the time of enrollment. * Abnormal laboratory values as defined per protocol. * Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal. * Patient not expected to survive at least 5 days. * Patient is pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of breakthrough proven/probable invasive fungal infection by day +100 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Spain
Contacts
Primary ContactJesus Fortun, MD, PhD
Outcome results
None listed