Clinical Trial: Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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).

Detailed Summary:

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.


Sponsor: Azienda Ospedaliera di Padova

Current Primary Outcome: Invasive Fungal Infection Free follow-up [ Time Frame: 1 month ]

Invasive Fungal Infection free control 1 month after beginning treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tolerance to treatment. [ Time Frame: 3 months ]
    Tolerance to treatment, with major focus on nephrotoxicity.
  • Study group mortality [ Time Frame: 3 months ]
    Assessment of study group mortality, compared to control
  • Study group morbidity [ Time Frame: 3 months ]
    Assessment of study group morbidity, compared to control
  • Invasive Fungal Infection-free percentage of study group [ Time Frame: 1 month ]
    Invasive Fungal Infection-free percentage of study group, evaluated at 1 month from beginning of study and assessment of mortality and morbidity in the control group


Original Secondary Outcome:

  • Tolerance to treatment. [ Time Frame: Duration of study ]
    Tolerance to treatment, with major focus on nephrotoxicity.
  • Study group mortality [ Time Frame: Duration of study ]
    Assessment of study group mortality, compared to control
  • Study group morbidity [ Time Frame: Duration of study ]
    Assessment of study group morbidity, compared to control
  • Invasive Fungal Infection-free percentage of study group [ Time Frame: 1 month ]
    Invasive Fungal Infection-free percentage of study group, evaluated at 1 month from beginning of study and assessment of mortality and morbidity in the control group


Information By: Azienda Ospedaliera di Padova

Dates:
Date Received: December 15, 2010
Date Started: May 2009
Date Completion: November 2012
Last Updated: July 17, 2012
Last Verified: July 2012