Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT00927316
Status:
COMPLETED
Last Update Posted:
2009-11-10
First Post:
2009-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)
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', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-09', 'studyFirstSubmitDate': '2009-06-22', 'studyFirstSubmitQcDate': '2009-06-23', 'lastUpdatePostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to UTI', 'timeFrame': '12 months'}, {'measure': 'Number of UTI', 'timeFrame': 'During 12 months placebo or active treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Report of Urinary Tract Infection episode'], 'conditions': ['Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes? The study is performed using a double-blind randomized study protocol with a cross-over, with re-inoculations being patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had bacteriuria or placebo-periods \\< 12 months will be subjected to additional patient blinded inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients are unaware of urine culture results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent UTI\n* Bladder emptying dysfunction\n* Optimal conservative treatment incl. clean intermittent catheterization\n* Capable of "self reporting of UTI episodes"\n\nExclusion Criteria:\n\n* Malignant disease\n* Immunosuppression\n* Recurrent pyelonephritis\n* Abnormalities within upper urinary tract, including renal stones and poor kidney function'}, 'identificationModule': {'nctId': 'NCT00927316', 'briefTitle': 'E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Induced Asymptomatic E. Coli 83972 Bacteriuria in Patients With Recurrent Urinary Tract Infections and Bladder Dysfunction- is There a Protective Effect Against Recurrent Symptomatic Infections? A Blinded Placebo Controlled Cross-over Study.', 'orgStudyIdInfo': {'id': 'RTP-A2003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active arm', 'description': 'E. coli 83972 bacteriuria', 'interventionNames': ['Biological: E. coli 83972']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Monitoring', 'interventionNames': ['Biological: E. coli 83972']}], 'interventions': [{'name': 'E. coli 83972', 'type': 'BIOLOGICAL', 'description': 'Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml).\n\nPlacebo arm: Identical procedure but with saline, 30 ml.', 'armGroupLabels': ['Active arm', 'Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Department of Urology, Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Fredrik Sundén, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Urology, University Hospital, 221 85 Lund'}, {'name': 'Björn Wullt, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. of Urology, Lund University Hospital, 221 85 Lund'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, {'name': 'Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden', 'class': 'UNKNOWN'}, {'name': 'Swedish Institute for Infectious Disease Control', 'class': 'OTHER'}, {'name': 'Lund University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Fredrik Sundén, MD', 'oldOrganization': 'Dept. of Urology, University Hospital, Lund, Sweden'}}}}