Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-01 @ 2:15 AM
Study NCT ID:
NCT00906633
Status:
COMPLETED
Last Update Posted:
2010-01-26
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seifem Surveillance of Antifungal Combination Therapy In Hematologic Italian Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-25', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety, efficacy and duration of therapy', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['antifungal therapies'], 'conditions': ['Fungal Infection']}, 'referencesModule': {'references': [{'pmid': '24373120', 'type': 'DERIVED', 'citation': "Candoni A, Caira M, Cesaro S, Busca A, Giacchino M, Fanci R, Delia M, Nosari A, Bonini A, Cattaneo C, Melillo L, Caramatti C, Milone G, Scime' R, Picardi M, Fanin R, Pagano L; SEIFEM GROUP (Sorveglianza Epidemiologica Infezioni Fungine nelle Emopatie Maligne). Multicentre surveillance study on feasibility, safety and efficacy of antifungal combination therapy for proven or probable invasive fungal diseases in haematological patients: the SEIFEM real-life combo study. Mycoses. 2014 Jun;57(6):342-50. doi: 10.1111/myc.12161. Epub 2013 Dec 23."}]}, 'descriptionModule': {'briefSummary': 'This trial is an observational study about combination antifungal therapy in hematologic patients with proven and probable invasive fungal infections (IFI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Haematologic patients with proven or probable invasive fungal infectious', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Haematologic patients with proven or probable IFI\n* Therapy with a combination of antifungal drugs\n\nExclusion Criteria:\n\n* Haematologic patients with possible IFI'}, 'identificationModule': {'nctId': 'NCT00906633', 'acronym': 'SEIFEM COMBO', 'briefTitle': 'Seifem Surveillance of Antifungal Combination Therapy In Hematologic Italian Centers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Udine, Italy'}, 'officialTitle': 'Seifem Observational Study of Antifungal Combination Therapy In Hematologic Italian Centers', 'orgStudyIdInfo': {'id': 'SEIFEMcombo0509'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Outcome of combination antifungal therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'University Hospital, Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'overallOfficials': [{'name': 'ANNA CANDONI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Udine, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Udine, Italy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'CANDONI ANNA', 'oldOrganization': 'UNIVERSITY HOSPITAL, Udine, Italy'}}}}