Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT05150327
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2021-11-25', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study of the incidence, risk factors and prognostic factors associated with invasive fungal filamentous fungal infections in liver transplant patients.', 'timeFrame': 'Files analysed retrospectively from January 01, 2007 to December 31, 2021 will be examined]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fungal Infection', 'Immunodeficiency', 'Fungal filamentous', 'Liver transplant', 'Organ transplant'], 'conditions': ['Fungal Infection']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with liver transplantation with proven nvasive fungal infection with filamentous fungus between 2007-2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age: from birth\n* Subject with a liver transplant in one of the centers participating in the study\n* Invasive fungal infection with filamentous fungus between 2007-2021\n* Proven or probable infection with filamentous fungi according to EORTC/MSGERC criteria:\n\n * Invasive aspergillosis\n * Mucormycosis\n * Fusariosis\n * Scedosporiosis\n * Other infection with filamentous fungus\n* Subject or legal representative for minors, who has not expressed, after information, his opposition to the reuse of his data for scientific research purposes.\n\nExclusion Criteria\n\n* Subject or (legal representative for minors) who has expressed his opposition to participating in the study\n* Subject not with a liver transplant\n* Subject under guardianship, curatorship or legal protection'}, 'identificationModule': {'nctId': 'NCT05150327', 'acronym': 'FongiFoie', 'briefTitle': 'Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Multicenter Retrospective Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients', 'orgStudyIdInfo': {'id': '8429'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'François DANION, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}