Prophylaxis With Caspofungin in High-Risk Liver Transplantation

Liver Transplantation Clinical Trial

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

Status Recruiting

Clinical Trial 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%.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fungal Infection
• Infection
• Liver Transplantation
• Mycoses

• NCT number: NCT00333645
• Study type: Interventional
• Source: Grupo de Estudio de Infecciones en Transplantados
• Contact: Jesus Fortun, MD, PhD
• Phone: +34-670-537460
• Email: fortun@mi.madritel.es
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2003
• Completion date: March 2007