Prophylaxis With Caspofungin in High-Risk Liver Transplantation

Grupo de Estudio de Infecciones en Transplantados

Status and phase

Unknown

Phase 2

Conditions

Fungal Infection

Liver Transplantation

Treatments

Drug: Caspofungin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00333645

GESITRA-01

03-0409 (Spanish Drug Agency)

Details and patient eligibility

About

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%.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.