Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-31 @ 1:51 AM
Study NCT ID:
NCT04937751
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2021-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Markers of Infection and Resistance in Invasive Fusariosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060585', 'term': 'Fusariosis'}], 'ancestors': [{'id': 'D060605', 'term': 'Hyalohyphomycosis'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074062', 'term': 'Environmental Biomarkers'}], 'ancestors': [{'id': 'D015415', 'term': 'Biomarkers'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004784', 'term': 'Environmental Monitoring'}, {'id': 'D004781', 'term': 'Environmental Exposure'}, {'id': 'D004787', 'term': 'Environmental Pollution'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and fungal strains'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-06-16', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis', 'timeFrame': '2021-2026'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fusariosis']}, 'descriptionModule': {'briefSummary': 'In recent decades, invasive fusarioses have been emerging fungal pathologies with high mortality. The prognosis depends on the speed of the diagnosis, but currently biological diagnosis is mainly based on fungal culture, no specific biomarker for this microorganism is available in current clinical practice. The genus Fusarium also shows reduced sensitivity to antifungals commonly used and recommended in clinical practice, such as voriconazole or amphotericin B.\n\nThe main objective of this study is to describe the proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis. The secondary objectives are the description of the dosage of galactomannans, beta (1,3) -D-glucans and the rate of detection of DNA circulating in case / control groups for the 2 clinical forms studied. In patients with evidence of Fusarium wilt, the study will describe the distribution of the different minimum inhibitory concentrations (MIC) depending on whether or not different antifungals are taken, the vital status at 3 months, and the response or not to treatment. Finally, the presence of genetic markers will be described according to the groups of MIC values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will have 2 parts:\n\n1. a first descriptive section carried out through a study of 2 cohorts of patients (patients suspected of IFI / with a diagnosis of keratitis) for whom a fungal culture is carried out;\n2. a second descriptive part (then potentially comparative if the statistical power is sufficient) carried out through 2 case-control studies nested in each of the patient cohorts (patients suspected of IFI / with a diagnosis of keratitis): these studies will consist of a population of cases (patients with Fusarium wilt) and 1 or 2 populations of controls (patients with negative culture on the one hand and patients with positive culture for a fungus of another genus in Fusarium on the other hand for invasive fusarioses).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspicion of invasive fungal infection involving the performance of a blood culture or a skin biopsy or diagnosis of keratitis involving the taking of a cornea sample\n* Fungal culture carried out on this sample\n* Person having been informed of the research and not having opposed the use of their data\n\nExclusion Criteria:\n\n* Clinical diagnosis of superficial fusarium wilt (onychomycosis, etc.)'}, 'identificationModule': {'nctId': 'NCT04937751', 'acronym': 'FUSIMIR', 'briefTitle': 'Markers of Infection and Resistance in Invasive Fusariosis', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Multicenter Study on Invasive Fusariosis : Looking for Markers of Infection and Resistance', 'orgStudyIdInfo': {'id': '2020PI202'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Invasive fusariosis', 'interventionNames': ['Diagnostic Test: biomarkers']}, {'label': 'Fusarium keratitis', 'interventionNames': ['Diagnostic Test: biomarkers']}], 'interventions': [{'name': 'biomarkers', 'type': 'DIAGNOSTIC_TEST', 'description': 'galactomannan, betaDglucan, resistance markers', 'armGroupLabels': ['Fusarium keratitis', 'Invasive fusariosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Debourgogne', 'role': 'CONTACT', 'email': 'a.debourgogne@chru-nancy.fr', 'phone': '+33383656074'}], 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Anne DEBOURGOGNE', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}