Liver Transplant European Study Into the Prevention of Fungal Infection | Completed
Liver Transplant European Study Int... | Completed
Liver Transplant European Study Into the Prevention of Fungal Infection
TENPIN

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Medical Conditions
  • Liver Transplantation
  • Mycoses
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01058174

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Prevention of invasive fungal infection in high risk patients following liver transplant.
Research Details
  • After receiving liver transplant, subjects will be randomized to one of the two treatment arms.

    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.
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Study Type
Interventional
Intervention
Drug : micafungin, Drug : fluconazole, Drug : liposomal amphotericin B, Drug : caspofungin

Study Arm Groups : micafungin, standard care, standard care, standard care

Intervention Type
See Interventions above
Primary Outcome Measures
    'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).; up to 21 days
Secondary Outcome Measures
    Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB; 3 months; Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator; up to 21 days & 3 months; Time to 'proven' or 'probable' IFD; up to 3 months; Fungal free survival at the End of Study and at the end of Long-term Follow-up; 3 months & 6 months; Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline; up to 21 days
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Undergoing orthotopic whole or split liver allograft transplantation

    - 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:

    - Any systemic antifungal therapy (excluding fluconazole or oral nystatin for a maximum of 7 days) within 14 days prior to randomization

    - 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Birmingham
B15 2TH
King's College Hospital
London
SE5 9RS
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Belgium, France, Germany, Hungary, Ireland, Italy, Portugal, Romania, Russian Federation, Saudi Arabia, Spain, Sweden, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
9463-EC-0001
Sponsor(s)
Astellas Pharma Inc
Key Dates

Recruitment Start Date

Dec 2009

Recruitment End Date

May 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

26 Jan 2010

Date updated in source

05 Jun 2015