Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT01393002
Status:
COMPLETED
Last Update Posted:
2013-10-18
First Post:
2011-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perception and Prevalence of Fungal Infections in Berlin - Brandenburg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D058387', 'term': 'Candidemia'}, {'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D058365', 'term': 'Candidiasis, Invasive'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D016469', 'term': 'Fungemia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-17', 'studyFirstSubmitDate': '2011-07-05', 'studyFirstSubmitQcDate': '2011-07-12', 'lastUpdatePostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perception and prevalence of fungal infections', 'timeFrame': '4 months', 'description': 'Perception and prevalence of fungal infections in ICU patients differs from real prevalence and leads to insufficient attribution of importance to this special medical condition.'}], 'secondaryOutcomes': [{'measure': 'Practice - Surrogate markers for diagnosis and therapy of fungal infection and retrospective analysis of cases of invasive mycosis in a peer-review setting.', 'timeFrame': '6 months', 'description': 'Qualitative and quantitative estimation of surrogate markers for diagnosis and treatment of invasive mycosis\n\nNumber of bloodcultures per year Rate of bloodcultures positive for fungi ICD-10 diagnosis ICU length of stay for patients with invasive mycosis and/or fungal infection Hospital mortality for patients with invasive mycosis and/or fungal infection Number of patients treated by antimycotics per year Mean duration of antifungal treatment Defined daily doses of antimycotics given by hospital pharmacy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intensive care', 'candidemia', 'fungal infection'], 'conditions': ['Invasive Mycosis']}, 'referencesModule': {'references': [{'pmid': '16127033', 'type': 'BACKGROUND', 'citation': 'Morrell M, Fraser VJ, Kollef MH. Delaying the empiric treatment of candida bloodstream infection until positive blood culture results are obtained: a potential risk factor for hospital mortality. Antimicrob Agents Chemother. 2005 Sep;49(9):3640-5. doi: 10.1128/AAC.49.9.3640-3645.2005.'}]}, 'descriptionModule': {'briefSummary': 'This is a structured web-based survey in selected hospitals with intensive care units in Berlin- Brandenburg that will focus on the analysis of current knowledge in ICUs in the field of invasive mycoses.', 'detailedDescription': 'Intensive care patients with invasive mycosis require a special clinical expertise especially in light of a high lethality. Early identification of patients at risk to develop a fungal infection is of utmost importance to start effective antifungal therapy. The implementation of current knowledge into clinical practice to fight fungal infection is not clear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Intensive care units of different primary and secondary care hospitals in the region of Berlin-Brandenburg.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intensive care units of hospitals in the INABBRA alliance.\n* Patients with invasive mycosis.\n\nExclusion Criteria:\n\n* Hospitals without intensive care unit.'}, 'identificationModule': {'nctId': 'NCT01393002', 'acronym': 'IFI_ICU', 'briefTitle': 'Perception and Prevalence of Fungal Infections in Berlin - Brandenburg', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Web-based Structured Survey of Retrospective Data of Invasive Mycosis in Intensive Care Patients in Berlin - Brandenburg', 'orgStudyIdInfo': {'id': 'IFI_ICU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'INABBRA', 'description': 'Participating hospitals in the INABBRA alliance.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Claudia Spies, Prof., MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}