Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2025-12-30 @ 4:50 AM
Study NCT ID:
NCT05656157
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2022-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Clinical Decision Support System for Fungal Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072742', 'term': 'Invasive Fungal Infections'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of concordance between the medical prescription and the recommendation of the clinical decision support system', 'timeFrame': 'January to september 2023'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['invasive fungal infections', 'antifungal treatment', 'clinical decision support system'], 'conditions': ['Invasive Fungal Infections']}, 'referencesModule': {'references': [{'pmid': '31982622', 'type': 'BACKGROUND', 'citation': 'Bienvenu AL, Pradat P, Guerin C, Aubrun F, Fellahi JL, Friggeri A, Guichon C, Hernu R, Menotti J, Monard C, Paulus S, Rimmele T, Piriou V, Chidiac C, Argaud L, Leboucher G. Evaluation of first-line therapies for the treatment of candidemia in ICU patients: A propensity score analysis. Int J Infect Dis. 2020 Apr;93:15-21. doi: 10.1016/j.ijid.2020.01.037. Epub 2020 Jan 23.'}, {'pmid': '35771615', 'type': 'RESULT', 'citation': 'Bienvenu AL, Pavese P, Leboucher G, Berger P, Roux S, Charmillon A, Foroni L, Menotti J, Lebeaux D, Mayan R, Mondain V, Robin C, Lesprit P, Alfandari S, Kerneis S. Practical checklist for implementation of antifungal stewardship programmes. J Med Microbiol. 2022 Jun;71(6). doi: 10.1099/jmm.0.001560.'}, {'pmid': '38656566', 'type': 'DERIVED', 'citation': 'Bienvenu AL, Cour M, Pavese P, Guichon C, Leray V, Chapuis C, Dureault A, Mohkam K, Gallet S, Bourget S, Kahale E, Chaabane W, Subtil F, Maucort-Boulch D, Talbot F, Dode X, Richard JC, Leboucher G. Correlation between antifungal clinical practices and a new clinical decision support system ANTIFON-CLIC(R) for the treatment of invasive candidiasis: a retrospective multicentre study. J Antimicrob Chemother. 2024 Jun 3;79(6):1407-1412. doi: 10.1093/jac/dkae118.'}]}, 'descriptionModule': {'briefSummary': 'Invasive fungal infections are serious and frequent diseases in our hospitals, especially in intensive care units. In accordance with the institutional recommendations, it is necessary to have a clinical decision support system to support the clinicians in a rapid and optimal prescription of antifungals for invasive fungal diseases. This clinical decision support system will benefit patients but also clinicians who will gain in medical efficiency. It will also have an ethical dimension since it will guarantee optimal antifungal treatments for all patients. The purpose of the research is to define the percentage of concordance between the medical prescription and the recommendation of the clinical decision support system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving antifungal therapy for the treatment of invasive fungal disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving antifungal therapy for the treatment of invasive fungal disease\n\nExclusion Criteria:\n\n* Patients not receiving antifungal therapy for the treatment of invasive fungal disease'}, 'identificationModule': {'nctId': 'NCT05656157', 'briefTitle': 'Evaluation of a Clinical Decision Support System for Fungal Infections', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of a Clinical Decision Support System for the Treatment of Invasive Fungal Infections', 'orgStudyIdInfo': {'id': 'CRC_GHN_2022_001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Antifungal treatment prescribed by the clinician for an invasive fungal disease'}, {'label': 'Antifungal treatment recommended by the clinical decision support system', 'interventionNames': ['Device: Medical device']}], 'interventions': [{'name': 'Medical device', 'type': 'DEVICE', 'description': 'Clinical decision support system', 'armGroupLabels': ['Antifungal treatment recommended by the clinical decision support system']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Anne-Lise Bienvenu, PharmD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}