Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients
NCT ID: NCT01260974
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
38 participants
INTERVENTIONAL
2009-05-31
2012-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Caspofungin
Study group
Caspofungin
50mg/dd for 21dd, starting within 24h from Liver Transplantation.
Interventions
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Caspofungin
50mg/dd for 21dd, starting within 24h from Liver Transplantation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Azienda Ospedaliera di Padova
OTHER
Responsible Party
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Prof. Umberto Cillo
Director of the Hepatobiliary Surgery and Liver Transplantation Unit
Principal Investigators
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Umberto Cillo, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria di Padova
Daniele Neri, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria di Padova
Locations
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Azienda Ospedaliera di Padova
Padua, Padova, Italy
Countries
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Central Contacts
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Facility Contacts
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Umberto Cillo, MD
Role: primary
Laura Saracino, MBS
Role: backup
Related Links
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Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)
Other Identifiers
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2008-007950-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1768P
Identifier Type: -
Identifier Source: org_study_id