Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients — CPHRLTX  

Mycoses Clinical Trial

Official title: Pilot Study: Efficacy of Caspofungin for Antifungal Prophylaxis for Selected High Risk Liver Transplant Patients

Status Recruiting

Clinical Trial Summary

The aim of the study is to determine viable use of caspofungin in post-OLTx patients, and to demonstrate in particular the effectiveness, understood as the ability to reduce the incidence of invasive fungal infections, and to assess the ability to reduce the risk and incidence of side effects (toxicity) which may arise in transplant patients treated with other drugs, especially in individuals recognized as high risk (e.g. renal failure).

Clinical Trial Description

The prophylactic use of anti-fungal drugs is crucial in order to decrease the incidence of invasive fungal infections in transplantation patients.

Invasive fungal infections (IFI) ---organ-related or systemic infections--- are in fact one of the most important causes of morbidity and mortality in patients undergoing solid organ transplantation (respectively, 70% and 100%).

The rationale of the proposed study is to evaluate a new protocol for the prevention of IFIs through the use of a newly introduced anti-fungal, caspofungin (commercial name: Cancidas), to be used for primary prophylaxis of fungal infections post-OLTx and to compare to drugs already in use (eg. amphotericin B, fluconazole), until 21 days after liver transplantation.

The aim of this study is determine viable use of caspofungin in post-OLTx patients, and to demonstrate in particular the effectiveness, understood as the ability to reduce the incidence of invasive fungal infections, and to assess the ability to reduce the risk and incidence of side effects (toxicity) which may arise in transplant patients treated with other drugs, especially in individuals recognized as high risk (e.g. renal failure).

The possibility of reducing the risk of fungal infections in liver transplant patients (usually between 7 and 42%) is therefore an important clinical goal. ;

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

• Fungemia
• Mycoses

• NCT number: NCT01260974
• Study type: Interventional
• Source: Azienda Ospedaliera di Padova
• Contact: Umberto Cillo, MD
• Phone: +390498218624
• Email: cillo@unipd.it
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2009
• Completion date: November 2012