Liver Transplant European Study Into the Prevention of Fungal Infection
NCT ID: NCT01058174
Last Updated: 2024-11-18
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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COMPLETED
PHASE3
350 participants
INTERVENTIONAL
2009-12-15
2012-05-03
Brief Summary
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Detailed Description
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Study drugs will be administered for a period of 21 days, or until hospital discharge, whichever occurs first.
Additionally, mortality data will be collected at the Long-term Follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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micafungin
intravenous infusion
micafungin
intravenous infusion
standard care
intravenous infusion
fluconazole
intravenous infusion
liposomal amphotericin B
intravenous infusion
caspofungin
intravenous infusion
Interventions
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micafungin
intravenous infusion
fluconazole
intravenous infusion
liposomal amphotericin B
intravenous infusion
caspofungin
intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients at 'high risk' of invasive fungal infection due to the presence of at least one of the following risk factors:
* Re-transplantation
* Acute liver failure
* Pre- or post-operative renal impairment (defined as creatinine clearance ≤40 ml/min) or need for renal replacement therapy
* Admission to Intensive Care Unit (ICU) for greater than 48 hours prior to liver transplant
* Re-operation (abdominal surgery) within 5 days of liver transplant
* Presence of choledocojejunostomy
* Perioperative colonization with fungi, defined as two or more positive clinical site surveillance cultures for Candida spp., obtained within 96 hours before or after liver transplant
* Need for prolonged mechanical ventilation for greater than 48 hours following liver transplant
* Transfusion intraoperatively of 20 or more units of cellular blood products
* Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain effective birth control during the study
Exclusion Criteria
* Evidence of documented ('proven' or 'probable') or suspected ('possible') IFD (according to the EORTC/MSG criteria)
* Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Europe Ltd.
Locations
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Innsbruck, , Austria
Antwerp, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Paris, Villejuif Cedex, France
Clichy, , France
Paris, , France
Toulouse, , France
Berlin, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Budapest, , Hungary
Dublin, , Ireland
Milan, , Italy
Padua, , Italy
Torino, , Italy
Udine, , Italy
Coimbra, , Portugal
Porto, , Portugal
Bucharest, , Romania
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Riyadh, , Saudi Arabia
Santiago de Compostela, A Coruna, Spain
Barakald, Vicaya, Spain
Barcelona, , Spain
Córdoba, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Stockholm, , Sweden
Birmingham, , United Kingdom
London, , United Kingdom
Countries
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References
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Saliba F, Pascher A, Cointault O, Laterre PF, Cervera C, De Waele JJ, Cillo U, Langer RM, Lugano M, Goran-Ericzon B, Phillips S, Tweddle L, Karas A, Brown M, Fischer L; TENPIN (Liver Transplant European Study Into the Prevention of Fungal Infection) Investigators; TENPIN Liver Transplant European Study Into the Prevention of Fungal Infection Investigators. Randomized trial of micafungin for the prevention of invasive fungal infection in high-risk liver transplant recipients. Clin Infect Dis. 2015 Apr 1;60(7):997-1006. doi: 10.1093/cid/ciu1128. Epub 2014 Dec 17.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2008-005214-49
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9463-EC-0001
Identifier Type: -
Identifier Source: org_study_id
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