Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-01 @ 3:27 PM
Study NCT ID:
NCT05039203
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-20
First Post:
2021-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacteriuria and Indwelling Urinary Catheter.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine samples for culture'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2021-09-01', 'studyFirstSubmitQcDate': '2021-09-01', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic bacteriuria (urinary tract infection)', 'timeFrame': 'Four weeks', 'description': 'Clinical diagnosis of urinary tract infection by a physician'}], 'secondaryOutcomes': [{'measure': 'Asymptomatic bacteriuria (ABU)', 'timeFrame': 'One day', 'description': 'Prevalence of ABU at the point of removal of an IUC compared with patients without IUC'}, {'measure': 'Persistence of ABU', 'timeFrame': 'Four weeks', 'description': 'For how long does ABU persist after IUC-removal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary Catheter'], 'conditions': ['Bacteriuria Asymptomatic', 'Urinary Tract Infections']}, 'referencesModule': {'references': [{'pmid': '39583881', 'type': 'DERIVED', 'citation': 'Kulbay A, Joelsson-Alm E, Amilon K, Tammelin A. Asymptomatic bacteriuria and urinary tract infection in geriatric inpatients after indwelling urinary catheter removal: a descriptive two-centre study. Infect Prev Pract. 2024 Oct 24;6(4):100411. doi: 10.1016/j.infpip.2024.100411. eCollection 2024 Dec.'}]}, 'descriptionModule': {'briefSummary': 'Investigation of 1. The incidence of symptomatic bacteriuria during four weeks after removal of an IUC in inpatients at a rehabilitation clinic for patients ≥ 65 years compared with the incidence of symptomatic bacteriuria among inpatients not treated with an IUC and 2. For how long does ABU persist in inpatients at a rehabilitation clinic for patients\n\n≥ 65 years during a follow-up time of four weeks after IUC-removal?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to a rehabilitation clinic for patients ≥ 65 years in Stockholm County, Sweden.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Admission to a rehabilitation clinic for patients ≥ 65 years in Stockholm County, Sweden\n* Ability to understand oral and written instructions in Swedish\n* Ability to produce a voided urine-sample\n\nExclusion Criteria:\n\n* Severe cognitive failure and/or disability to understand oral and written instructions in Swedish according to the healthcare-personnel's judgment at the ward\n* End-of-life care\n* Physical disability to produce voided urine-samples\n* Ongoing antimicrobial treatment for symptomatic bacteriuria"}, 'identificationModule': {'nctId': 'NCT05039203', 'briefTitle': 'Bacteriuria and Indwelling Urinary Catheter.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Stockholm'}, 'officialTitle': 'The Risk of Symptomatic Bacteriuria and Persistence of Asymptomatic Bacteriuria After Removal of an Indwelling Urinary Catheter- a Prospective Observational Study Among Elderly Inpatients.', 'orgStudyIdInfo': {'id': '2021-02410'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention group', 'description': 'Inpatients with an indwelling urinary catheter (IUC) at admission to a rehabilitation clinic for persons ≥65 years in Sweden. Intervention is removal of the IUC.', 'interventionNames': ['Device: Indwelling urinary catheter']}, {'label': 'Control group', 'description': 'Inpatients without an IUC at admission to a rehabilitation clinic for persons ≥65 years in Sweden'}], 'interventions': [{'name': 'Indwelling urinary catheter', 'type': 'DEVICE', 'description': 'Removal of indwelling urinary catheter', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Södertälje', 'country': 'Sweden', 'facility': 'Geriatric Department, Södertälje Hospital', 'geoPoint': {'lat': 59.19554, 'lon': 17.62525}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Geriatric Department, Danderyd Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor', 'investigatorFullName': 'Ann Tammelin', 'investigatorAffiliation': 'Region Stockholm'}}}}