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FongiFoie: Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05150327
Collaborator
(none)
300
Enrollment
1
Location
23.9
Anticipated Duration (Months)
12.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are frequent and serious in immunocompromised individuals and especially in organ transplant patients. There is little recent data in liver transplantation, especially on the incidence and risk factors of fungal infections

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Multicenter Retrospective Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
    Actual Study Start Date :
    Nov 1, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Oct 29, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Study of the incidence, risk factors and prognostic factors associated with invasive fungal filamentous fungal infections in liver transplant patients. [Files analysed retrospectively from January 01, 2007 to December 31, 2021 will be examined]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion criteria

    • Age ≥18 years old

    • Subject with liver transplantation in one of the centers participating in the study

    • Invasive fungal infection with filamentous fungus between 2007-2021

    • Proven or probable infection with filamentous fungi according to the EORTC / MSGERC criteria

    • Subject not having expressed, after information, his opposition to the reuse of his data for scientific research purposes.

    Non-inclusion criteria

    • Subject having expressed opposition to participating in the study

    • Subject not transplanted liver

    • Subject under guardianship, curatorship or safeguard of justice

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Study Director: François DANION, MD, Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05150327
    Other Study ID Numbers:
    • 8429
    First Posted:
    Dec 9, 2021
    Last Update Posted:
    Dec 9, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Fungal Infection
    Immunodeficiency
    Fungal filamentous
    Liver transplant
    Organ transplant
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Mycoses

    Study Results

    No Results Posted as of Dec 9, 2021