Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-01 @ 7:47 PM
Study NCT ID:
NCT01060956
Status:
COMPLETED
Last Update Posted:
2011-07-27
First Post:
2010-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-26', 'studyFirstSubmitDate': '2010-02-01', 'studyFirstSubmitQcDate': '2010-02-01', 'lastUpdatePostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of antibiotic treatment', 'timeFrame': 'During the episode of urinary tract infection'}], 'secondaryOutcomes': [{'measure': 'Days to clinical resolution', 'timeFrame': 'Duration of urinary tract infection and duration of hospitalization'}, {'measure': 'Increase/decrease in the spectrum of antibiotic', 'timeFrame': 'Duration of urinary tract infection and duration of hospitalization'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'Duration of urinary tract infection and duration of hospitalization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Urinary tract infection with two bacteria in culture'], 'conditions': ['Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether identification of two different bacteria in urine culture of patients with indwelling catheter has a clinical impact - change in antibiotic, duration of antibiotic, days to clinical resolution and length of stay in hospital.\n\nThe microbiology laboratory will randomized urine cultures with two bacteria from indwelling catheter to either reporting identity and susceptibility of the bacteria or reporting "mixed growth".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults hospitalized with indwelling urinary catheter in growth of two bacteria in urine culture\n\nExclusion Criteria:\n\n* Positive blood cultures or no blood cultures taken'}, 'identificationModule': {'nctId': 'NCT01060956', 'briefTitle': 'The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures', 'orgStudyIdInfo': {'id': 'UTI1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Reporting on two bacteria in urine culture', 'description': 'The microbiology laboratory will report on the isolation and susceptibilities of two different bacteria in urine culture', 'interventionNames': ['Other: reporting of two different bacteria in urine culture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'reporting "mixed growth"', 'description': 'The microbiology laboratory will report on mixed growth in urine culture', 'interventionNames': ['Other: reporting "mixed growth" on urine culture']}], 'interventions': [{'name': 'reporting of two different bacteria in urine culture', 'type': 'OTHER', 'description': 'reporting of two different bacteria in urine culture', 'armGroupLabels': ['Reporting on two bacteria in urine culture']}, {'name': 'reporting "mixed growth" on urine culture', 'type': 'OTHER', 'description': 'reporting "mixed growth" on urine culture', 'armGroupLabels': ['reporting "mixed growth"']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Amos M Yinnon, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebrew university, Jerusalem, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Shaare Zedek Medical Center', 'oldOrganization': 'Shaare Zedek Medical Center'}}}}