Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-09 @ 1:59 AM
Study NCT ID:
NCT04098133
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2019-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of Carbapenemase-producing Bacteria in a Swiss Tertiary Care Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D003710', 'term': 'Demography'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-09-17', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of CPB at the University Hospital Basel (number)', 'timeFrame': 'from January 1st , 2008 until December 31st, 2028', 'description': 'incidence of CPB at the University Hospital Basel (number)'}], 'secondaryOutcomes': [{'measure': 'time to detection of CPB (days)', 'timeFrame': 'from January 1st , 2008 until December 31st, 2028', 'description': 'time to detection of CPB (days)'}, {'measure': 'time to initiation of infection control measures', 'timeFrame': 'from January 1st , 2008 until December 31st, 2028', 'description': 'time to initiation of infection control measures'}, {'measure': 'time to adequate treatment in patients with CPB infections', 'timeFrame': 'from January 1st , 2008 until December 31st, 2028', 'description': 'time to adequate treatment in patients with CPB infections'}, {'measure': 'presence of established risk factors for CPB', 'timeFrame': 'from January 1st , 2008 until December 31st, 2028', 'description': 'presence of established risk factors for CPB'}, {'measure': 'length of hospital stay (days)', 'timeFrame': 'from January 1st , 2008 until December 31st, 2028', 'description': 'length of hospital stay (days)'}, {'measure': 'discharge destination', 'timeFrame': 'from January 1st , 2008 until December 31st, 2028', 'description': 'discharge destination'}, {'measure': 'cure from infection', 'timeFrame': 'from January 1st , 2008 until December 31st, 2028', 'description': 'cure from infection'}, {'measure': 'cause-specific mortality (number)', 'timeFrame': 'from January 1st , 2008 until December 31st, 2028', 'description': 'cause-specific mortality (number)'}, {'measure': 'all-cause mortality (number)', 'timeFrame': 'from January 1st , 2008 until December 31st, 2028', 'description': 'all-cause mortality (number)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carbapenemase-producing Klebsiella pneumoniae', 'antibiotic resistancy', 'infections with Carbapenemase-producing Bacteria (CPB)', 'Carbapenemase-producing Bacteria'], 'conditions': ['Infections With CPB']}, 'descriptionModule': {'briefSummary': 'This retrospective and prospective study is to investigate the incidence of Carbapenemase-producing bacteria (CPB) at the University Hospital Basel, the time to detection of CPB and to initiation of infection control measures, the risk factors associated with carriage of CPB, type and duration of previously administrated antibiotic medication, antibiotic treatment, as well as to assess the outcomes of the affected patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated in the in- or outpatient setting at the University Hospital Basel with detection of carbapenemase-producing bacteria in any screening or clinical sample from January 1st , 2008 until December 31st , 2028', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with detection of carbapenemase-producing bacteria from January 1st , 2008 until December 31st , 2028\n\nExclusion Criteria:\n\n* Patients with documented refusal of subsequent use of their data'}, 'identificationModule': {'nctId': 'NCT04098133', 'acronym': 'CPB-Epi Basel', 'briefTitle': 'Epidemiology of Carbapenemase-producing Bacteria in a Swiss Tertiary Care Hospital', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Epidemiology of Carbapenemase-producing Bacteria in a Swiss Tertiary Care Hospital', 'orgStudyIdInfo': {'id': '2019-01548; me19Tschudinsutter'}}, 'armsInterventionsModule': {'interventions': [{'name': 'data collection for demographic data', 'type': 'OTHER', 'description': 'data collection for demographic data (age, gender, hospital admission and discharge date, length of stay, hospitalization prior to current hospital stay (acute care facilities, long-term healthcare centres, nursing homes), discharge destination, outcome, cause of death, travel history, previous exposure to antibiotics and proton pump Inhibitors)'}, {'name': 'data collection for clinical data', 'type': 'OTHER', 'description': 'data collection for clinical data (comorbidities, Charlson Comorbidity Index, immunosuppressive treatment, date of diagnosis of CPB, days between hospital admission and diagnosis of CPB, type of consecutive infection, indwelling vascular hardware, urinary catheterization, surgical therapies)'}, {'name': 'data collection for treatment data', 'type': 'OTHER', 'description': 'data collection for treatment data (antibiotic therapy, immunosuppressive therapy, concomitant medication)'}, {'name': 'data collection for microbiological data', 'type': 'OTHER', 'description': 'data collection for microbiological data (species of CPB, type of sample, date of sample, history of colonization or infection with any antibiotic resistant pathogen)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Sarah Tschudin Sutter, PD MD', 'role': 'CONTACT', 'email': 'sarah.tschudin@usb.ch', 'phone': '+41 61 328 68 10'}, {'name': 'Isabelle Vock, Dipl. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Division of Infectious Diseases and Hospital Epidemiology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Sarah Tschudin Sutter, Prof. Dr. MD', 'role': 'CONTACT', 'email': 'sarah.tschudin@usb.ch', 'phone': '+41 61 328 68 10'}, {'name': 'Isabelle Vock, Dipl. med', 'role': 'CONTACT', 'email': 'isabelle.vock@usb.ch'}], 'overallOfficials': [{'name': 'Sarah Tschudin Sutter, Prof. Dr. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}