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

September 16, 2024 updated by: University Hospital, Strasbourg, France

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with liver transplantation with proven nvasive fungal infection with filamentous fungus between 2007-2021

Description

Inclusion Criteria

  • Age: from birth
  • Subject with a liver transplant 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 EORTC/MSGERC criteria:

    • Invasive aspergillosis
    • Mucormycosis
    • Fusariosis
    • Scedosporiosis
    • Other infection with filamentous fungus
  • Subject or legal representative for minors, who has not expressed, after information, his opposition to the reuse of his data for scientific research purposes.

Exclusion Criteria

  • Subject or (legal representative for minors) who has expressed his opposition to participating in the study
  • Subject not with a liver transplant
  • Subject under guardianship, curatorship or legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2021

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8429

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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