Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-04 @ 5:54 PM
Study NCT ID:
NCT01108757
Status:
TERMINATED
Last Update Posted:
2017-10-18
First Post:
2010-04-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}], 'ancestors': [{'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'borzil@ccf.org', 'phone': '2164453158', 'title': 'Lynn Borzi', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3-years while patients were in treatment and follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Drug', 'description': 'Bactrim: Bactrim DS BID for 3 days', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: Corn starch capsules', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Urinary Tract Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug', 'description': 'Bactrim: Bactrim DS BID for 3 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Corn starch capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days following catheter removal', 'description': 'Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as \\>100,000 colony forming units/mL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated early.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Drug', 'description': 'Bactrim: Bactrim DS BID for 3 days'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: Corn starch capsules'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 52 subjects were recruited.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Drug', 'description': 'Bactrim: Bactrim DS BID for 3 days\n\nDemographics data by group not available as this study was discontinued in 2013. Currently randomization data not available for reassessment.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: Corn starch capsules'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Mean Age', 'categories': [{'measurements': [{'value': '60', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '58', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '59', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '27.2', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '3.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index (BMI) measured as kg/m\\^2', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'whyStopped': 'Unfeasible because of low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-17', 'studyFirstSubmitDate': '2010-04-21', 'resultsFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2010-04-21', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-17', 'studyFirstPostDateStruct': {'date': '2010-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Urinary Tract Infection', 'timeFrame': '7 days following catheter removal', 'description': 'Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as \\>100,000 colony forming units/mL'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['catheter', 'urinary tract infection'], 'conditions': ['Catheter-Associated Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Requires catheterization \\>24h hours following incontinence or pelvic reconstructive surgery\n\nExclusion Criteria:\n\n* Receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization\n* Allergy to sulfonamides or trimethoprim\n* Non-English speaking\n* Pregnancy\n* Breast feeding\n* Severe renal impairment (creatinine clearance \\<30)\n* Patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate.'}, 'identificationModule': {'nctId': 'NCT01108757', 'acronym': 'PRECAUTION', 'briefTitle': 'Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Prevention of Catheter-Associated Urinary Tract Infections in Patients Undergoing Incontinence and Reconstructive Pelvic Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '10-125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug', 'interventionNames': ['Drug: Bactrim']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Bactrim', 'type': 'DRUG', 'description': 'Bactrim DS BID for 3 days', 'armGroupLabels': ['Drug']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Corn starch capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Matthew D Barber, MD MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Urogynecologic Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}