Clinical trial NCT01260974: Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients
Official title: Pilot Study: Efficacy of Caspofungin for Antifungal Prophylaxis for Selected High Risk Liver Transplant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fungemia
Mycoses
Keywords: Invasive fungal infections
Liver Transplantation
Organ Transplantation
Mycoses
Fungus Diseases
Antifungal Agents
Invasive Mycosis
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-12-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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.

Eligibility 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.

Primary outcomes:
measure: Invasive Fungal Infection Free follow-up
timeFrame: 1 month
Secondary outcomes:
measure: Tolerance to treatment.
timeFrame: 3 months
measure: Study group mortality
timeFrame: 3 months
measure: Study group morbidity
timeFrame: 3 months
measure: Invasive Fungal Infection-free percentage of study group
timeFrame: 1 month
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
Study officials:
affiliation: Azienda Ospedaliera Universitaria di Padova
name: Umberto Cillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Universitaria di Padova
name: Daniele Neri, MD
role: PRINCIPAL_INVESTIGATOR
References: