Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients

Condition(s) targeted: Fungemia; Mycoses

Intervention: Caspofungin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Azienda Ospedaliera di Padova

Official(s) and/or principal investigator(s):
Umberto Cillo, MD, Principal Investigator, Affiliation: Azienda Ospedaliera Universitaria di Padova
Daniele Neri, MD, Principal Investigator, Affiliation: Azienda Ospedaliera Universitaria di Padova

Overall contact:
Umberto Cillo, MD, Phone: +390498218624, Email: cillo@unipd.it

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).

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

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

Primary outcome: Invasive Fungal Infection Free follow-up

Secondary outcome:

Tolerance to treatment.

Study group mortality

Study group morbidity

Invasive Fungal Infection-free percentage of study group

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients shortlisted for liver transplantation

- negative pregnancy test for fertile female patients 7 days prior enrollment

- patients who can adequately communicate with study responsibles, who can understand

and answer to protocol requirements At least one of the following criteria:

- MELD score ≥25

- liver transplantation for acute liver failure

- liver re-transplantation

- fever without bacterial or viral infection

- biliodigestive

- re-laparatomy after LTx

- post LTx pancreatitis

- post LTx dialysis or renal insufficiency

Exclusion Criteria:

- Patients enrolled in other clinical trial or those having received other experimental

drugs 4 weeks prior to enrollment

- Patients with a known fungal infection (based on the EORTC/MSG criteria)

- Patients with history of hypersensitivity to the drug, or other counterindications

- Patients with a diagnosed Severe Hepatic insufficiency (CTP >9)

- Physical or hematochemical alterations

- Clinically relevant psychological alterations in the 2 weeks preceding enrollment

such as to interfere, in the researchers opinion, with the goal of the study

- Patients being treated with Ciclosporin A

Subjects being removed from the trial shall be replaced.

Umberto Cillo, MD, Phone: +390498218624, Email: cillo@unipd.it

Azienda Ospedaliera di Padova, Padova 35128, Italy; Recruiting
Umberto Cillo, MD, Phone: +390498218624, Email: cillo@unipd.it
Laura Saracino, MBS, Phone: +390498218624, Email: lasaracino@gmail.com
Umberto Cillo, MD, Principal Investigator
Daniele Neri, MD, Sub-Investigator
Giacomo Zanus, MD, Sub-Investigator
Patrizia Boccagni, MD, Sub-Investigator
Enrico Gringeri, MD, Sub-Investigator
Francesco D'Amico, MD, Sub-Investigator
Alessandro Vitale, MD, Sub-Investigator
Paolo Feltracco, MD, Sub-Investigator
Dino Sgarabotto, MD, Sub-Investigator
Pasquale Bonsignore, MD, Sub-Investigator
Marina Polacco, MD, Sub-Investigator
Enrico Lodo, MD, Sub-Investigator
Davide Du Puis, MD, Sub-Investigator
Laura Saracino, MBS, Sub-Investigator

Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)

Starting date: May 2009
Last updated: July 17, 2012