Status:
UNKNOWN
Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients
Lead Sponsor:
Azienda Ospedaliera di Padova
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Fungemia
Mycoses
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01260974
Start Date
May 1 2009
End Date
November 1 2012
Last Update
July 18 2012
Active Locations (1)
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1
Azienda Ospedaliera di Padova
Padua, Padova, Italy, 35128