Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT06808451
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019105', 'term': 'Random Amplified Polymorphic DNA Technique'}], 'ancestors': [{'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in symptoms as measured by UTI-SIQ-8 questionnaire', 'timeFrame': 'Baseline, one day after antibiotic completion', 'description': 'The UTI-SIQ-8 is an eight item questionnaire that asks about symptom severity and symptom impairment on a likert scale from 0 to 4, 0 being not at all and 4 being very strong/very severe.'}, {'measure': 'Change in symptoms as measured by the UTI Symptom Assessment questionnaire', 'timeFrame': 'Baseline, one day after antibiotic completion', 'description': 'The UTI Symptom Assessment questionnaire is a ten item questionnaire that asks about symptom relief, with lower scores indicating less symptoms.'}], 'secondaryOutcomes': [{'measure': 'Length of time from patient presentation to initiation of treatment as measured by medical record review', 'timeFrame': 'Up to 21 days'}, {'measure': 'Number of antibiotic changes as measured by medical record review', 'timeFrame': 'Up to 21 days'}, {'measure': 'Duration of antibiotic use as measured by medical record review', 'timeFrame': 'Up to 21 days', 'description': 'Duration will be measured in days'}, {'measure': 'Number of times participant represents with UTI symptoms as measured by medical record review', 'timeFrame': 'Up to 30 days', 'description': 'Duration will be measured in days'}, {'measure': 'Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review', 'timeFrame': 'Up to 21 days'}, {'measure': 'Number of hospitalizations related to UTI as measured by medical record review', 'timeFrame': 'Up to 21 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['urine culture', 'DNA PCR'], 'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult men and women 18 years and older\n* Presenting to clinic with symptoms of UTI or cystitis\n* Patients with Medicare and Medicaid insurance\n\nExclusion Criteria:\n\n* Urinary diversion of any type\n* Chronic indwelling urinary catheter\n* Diagnosed UTI within the previous 21 days\n* Antibiotic therapy within the previous 21 days\n* Use of phenazopyridine within the previous 21 days\n* Commercial insurance\n* Non-English speaking\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT06808451', 'briefTitle': 'Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STUDY20241345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DNA Polymerase Chain Reaction (PCR)', 'description': 'Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.', 'interventionNames': ['Device: DNA PCR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Urine Culture', 'description': 'Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.', 'interventionNames': ['Diagnostic Test: Urine Culture']}], 'interventions': [{'name': 'DNA PCR', 'type': 'DEVICE', 'description': 'Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.', 'armGroupLabels': ['DNA Polymerase Chain Reaction (PCR)']}, {'name': 'Urine Culture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.', 'armGroupLabels': ['Urine Culture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diana N Mitchell, MD, MBA, BSN', 'role': 'CONTACT', 'email': 'diana.mitchell@uhhospitals.org', 'phone': '216-844-1000'}], 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Diana N Mitchell, MD, MBA, BSN', 'role': 'CONTACT', 'email': 'diana.mitchell@uhhospitals.org', 'phone': '216-844-1000'}], 'overallOfficials': [{'name': 'David Sheyn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Division of Urogynecology and Reconstructive Pelvic Surgery', 'investigatorFullName': 'David Sheyn', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}