Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-28 @ 1:10 AM
Study NCT ID:
NCT04982159
Status:
COMPLETED
Last Update Posted:
2022-06-02
First Post:
2021-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Minimum Inhibitory Concentration and Clinical Outcome of 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-27', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Evolution', 'timeFrame': '6 weeks after diagnosis', 'description': 'Retrospective evaluation of death rate.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['invasive fusariosis', 'minimum inhibitory concentration'], 'conditions': ['Invasive Fusariosis']}, 'descriptionModule': {'briefSummary': 'Multi-centered, international, observational and retrospective study to analyze the correlation between MIC and clinical outcome in patients with invasive fusariosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital patients diagnosed with invasive fusariosis.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive fusariosis diagnostic\n* Proof of anti-fungic susceptibility according to EUCAST or CLSI, for the medicine used in the treatment of invasive fusariosis.\n* Available data about anti-fungic medicines used: name of medicine, start and end date of treatment.\n* Available information about clinical outcome of illness after 30 days, 6 weeks and 90 days (dead or alive).\n* Only cases of invasive fusariosis proven or possible will be included.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04982159', 'briefTitle': 'Correlation Between Minimum Inhibitory Concentration and Clinical Outcome of Invasive Fusariosis', 'organization': {'class': 'OTHER', 'fullName': 'Maimónides Biomedical Research Institute of Córdoba'}, 'officialTitle': 'Correlation Between Minimum Inhibitory Concentration and Clinical Outcome of Invasive Fusariosis', 'orgStudyIdInfo': {'id': 'FIB-VOR-2019-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Invasive Fusariosis', 'description': 'Patients hospitalized with an invasive fusariosis diagnostic in the stablished period of study.', 'interventionNames': ['Other: There is no intervention. This is an observational study.']}], 'interventions': [{'name': 'There is no intervention. This is an observational study.', 'type': 'OTHER', 'description': 'There is no intervention. This is an observational study.', 'armGroupLabels': ['Invasive Fusariosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}]}, 'ipdSharingStatementModule': {'url': 'https://pubmed.ncbi.nlm.nih.gov/33326585/', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'When study is published.', 'ipdSharing': 'YES', 'description': 'Data will be shared after the study concludes and results are published.', 'accessCriteria': 'Through request to Principal Investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maimónides Biomedical Research Institute of Córdoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}