Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-29 @ 5:43 PM
Study NCT ID:
NCT02915692
Status:
TERMINATED
Last Update Posted:
2016-09-27
First Post:
2012-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare CAUTI Rates Following ERASE CAUTI Tray Silver vs Silver Coated Foley Catheters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 753}}, 'statusModule': {'whyStopped': 'Withdrawn funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-23', 'studyFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2016-09-23', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary tract infection rates', 'timeFrame': '2 days on average or until hospital discharge', 'description': 'Infection rate/1000 catheter days based on days of use. As the number of days a catheter is used varies, the minimum expected time frame on average is 2 days. However, infections will be monitored during catheter use.'}], 'secondaryOutcomes': [{'measure': 'Catheter use', 'timeFrame': '2 days on average or until hospital discharge', 'description': 'The average number of days a catheter is used is typically 2 days. However during the hospital stay, the time a catheter remains varies on medical need. The total daily use of each catheter will be tabulated after removal..'}, {'measure': 'Catheter Associated Urinary Track Infection Costs', 'timeFrame': 'Post Infection costs incurred from insertion of catheter to hospital discharge (<30 days)', 'description': 'Costs associated with urinary track Infections during the use of a catheter in the study will calculated from the time infection was identified until hospital discharge.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Foley', 'CAUTI', 'ERASE CAUTI'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'The Foley catheter is one component in a catheter insertion procedure that could contribute to a catheter associated urinary tract infection (CAUTI). Improvements in the catheter insertion procedure using the ERASE CAUTI Tray system may help to lower these infection rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects requiring Foley catheters', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Received either silver coated Foley catheter or ERASE CAUTI silver coated catheter\n\nExclusion Criteria:\n\n* UTI present upon current hospital admission\n* Burn patients, transplant patients, or immune-compromised patients.'}, 'identificationModule': {'nctId': 'NCT02915692', 'briefTitle': 'Study to Compare CAUTI Rates Following ERASE CAUTI Tray Silver vs Silver Coated Foley Catheters', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medline Industries'}, 'officialTitle': 'A Clinical Study to Compare the CAUTI Rates Following ERASE CAUTI Tray Silver Coated Foley Catheters Verse Silver Coated Foley Catheters', 'orgStudyIdInfo': {'id': 'MII-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ERASE Silver Coated Foley Catheters', 'description': 'Subjects given silver catheters from an ERASE CAUTI Tray.', 'interventionNames': ['Device: ERASE Silver Coated Foley Catheter']}, {'label': 'Comparator Silver Coated Catheter', 'description': 'Comparator silver urinary catheter', 'interventionNames': ['Device: Comparator Silver Coated Catheter']}], 'interventions': [{'name': 'ERASE Silver Coated Foley Catheter', 'type': 'DEVICE', 'otherNames': ['Silver coated Foley catheter'], 'description': 'Foley catheter from ERASE CAUTI Kit will be administered as required.', 'armGroupLabels': ['ERASE Silver Coated Foley Catheters']}, {'name': 'Comparator Silver Coated Catheter', 'type': 'DEVICE', 'otherNames': ['Silver coated catheter'], 'description': 'Foley catheter coated with silver', 'armGroupLabels': ['Comparator Silver Coated Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31061', 'city': 'Milledgenville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Oconnee Regional Medical Center'}], 'overallOfficials': [{'name': 'S T Symeonides, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parish Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medline Industries', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}