Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT03554603
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2018-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Modified Reporting of Positive Urine Cultures Collected From Long Term Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pkd336@mun.ca', 'phone': '7097772089', 'title': 'Peter Daley MD MSc', 'organization': 'Memorial University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Bacteremia during the trial was considered a serious adverse event', 'eventGroups': [{'id': 'EG000', 'title': 'Modified Reporting', 'description': 'Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results"\n\nModified Report: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 34, 'seriousNumAtRisk': 51, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Reporting', 'description': 'Microbiology laboratory will report identification and susceptibility results', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 27, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Temperature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated White Blood Cell Count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Altered Mental Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachypnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bacteremia', 'notes': 'Positive blood culture during study period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Reporting', 'description': 'Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results"\n\nModified Report: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important.'}, {'id': 'OG001', 'title': 'Standard Reporting', 'description': 'Microbiology laboratory will report identification and susceptibility results'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Number of Participants Who Received Appropriate Antibiotic Treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Modified Reporting', 'description': 'Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results"\n\nModified Report: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important.'}, {'id': 'FG001', 'title': 'Standard Reporting', 'description': 'Microbiology laboratory will report identification and susceptibility results'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Modified Reporting', 'description': 'Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results"\n\nModified Report: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important.'}, {'id': 'BG001', 'title': 'Standard Reporting', 'description': 'Microbiology laboratory will report identification and susceptibility results'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '76.1', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '74.0', 'spread': '17.7', 'groupId': 'BG001'}, {'value': '75.0', 'spread': '15.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Urinary Tract Infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Asymptomatic Bacteriuria', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-01', 'size': 240402, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-05T13:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2018-06-01', 'resultsFirstSubmitDate': '2022-09-05', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-26', 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics', 'timeFrame': '7 days', 'description': 'Number of Participants Who Received Appropriate Antibiotic Treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Long term care', 'Urine culture'], 'conditions': ['Urinary Tract Infections', 'Asymptomatic Bacteriuria']}, 'descriptionModule': {'briefSummary': 'Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. The restricted report may reduce the rate of inappropriate treatment of AB.', 'detailedDescription': 'Positive urine cultures during the study period will be randomized to restricted microbiology laboratory reporting or standard microbiology laboratory reporting. Physician or patient consent will not be collected. Patient records will be assessed by the investigator to determine if patients have AB or urinary tract infection. Physician antibiotic treatment decision in both groups will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Consecutive positive urine cultures collected from patients admitted to Long term care facilities will be included. All methods of urine collection will be included (midstream, in-and-out catheterization, indwelling catheter).\n\nExclusion Criteria:\n\n1. Positive urine cultures not collected from Long term care facility patients\n2. Pregnancy\n3. Antibiotic treatment at the time of collection\n4. Patients known to have blood neutrophils \\<1.0 within 7 days of urine collection'}, 'identificationModule': {'nctId': 'NCT03554603', 'briefTitle': 'Modified Reporting of Positive Urine Cultures Collected From Long Term Care', 'organization': {'class': 'OTHER', 'fullName': 'Memorial University of Newfoundland'}, 'officialTitle': 'Modified Reporting of Positive Urine Cultures Collected From Long Term Care, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MUN-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Reporting', 'description': 'Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results"', 'interventionNames': ['Behavioral: Modified Report']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Reporting', 'description': 'Microbiology laboratory will report identification and susceptibility results'}], 'interventions': [{'name': 'Modified Report', 'type': 'BEHAVIORAL', 'otherNames': ['Restricted Report'], 'description': 'An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important.', 'armGroupLabels': ['Modified Reporting']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A1B3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Health Sciences Center', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial University of Newfoundland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Peter Daley', 'investigatorAffiliation': 'Memorial University of Newfoundland'}}}}