NCT00333645

Prophylaxis With Caspofungin in High-Risk Liver Transplantation

Prophylaxis With Caspofungin for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (planned)
• Sponsor: Grupo de Estudio de Infecciones en Transplantados · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Liver Transplantation
• Fungal Infection

Interventions

Type	Name	Description
DRUG	Caspofungin

Timeline

• Start date: 2003-10-01
• Completion: 2007-03-01
• First posted: 2006-06-06
• Last updated: 2007-04-13

Locations

13 sites across 1 country: Spain