Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients (CPHRLTX)

University of Padua

Status and phase

Unknown

Phase 2

Conditions

Fungemia

Mycoses

Treatments

Drug: Caspofungin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01260974

2008-007950-36 (EudraCT Number)

1768P

Details and patient eligibility

About

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).

Full 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.

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.