Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-24 @ 12:22 PM
Study NCT ID:
NCT02130518
Status:
UNKNOWN
Last Update Posted:
2015-12-02
First Post:
2014-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2014-05-01', 'studyFirstSubmitQcDate': '2014-05-01', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent flow rate reduction of study catheters at time of removal', 'timeFrame': 'Up to 29 Days'}], 'secondaryOutcomes': [{'measure': 'Number of study catheters removed due to clinical catheter blockage', 'timeFrame': 'Up to 29 days'}, {'measure': 'Number of subjects with serious and non-serious adverse events', 'timeFrame': 'Up to 29 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urinary Catheter Blockage and Encrustation']}, 'descriptionModule': {'briefSummary': 'Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract infections and blockage caused by crystalline biofilm accumulation (encrustation) of the catheter surfaces. When the urine and catheter are colonized by urease-producing bacteria such as Proteus mirabilis, encrustation of the catheter is likely to occur.\n\nThe use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs and better patient quality of life.\n\nAuriclosene is a non-antibiotic, fast-acting, broad-spectrum antimicrobial, which exhibits potential for the rapid decolonization of a range of urologic pathogens, including the urease-producing Proteus mirabilis.\n\nSubjects will be randomized to either Auriclosene Irrigation Solution or Auriclosene Vehicle solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject requiring an indwelling urinary catheter with a history of catheter blockage and/or encrustation\n* Screening within 30 days of randomization\n\nExclusion Criteria:\n\n* Systemic antibiotic use within 14 days of first treatment\n* Investigational drug or device within 30 days if enrollment\n* Current infection requiring treatment with systemic antibiotics\n* Pregnant or lactating female'}, 'identificationModule': {'nctId': 'NCT02130518', 'briefTitle': 'Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency', 'organization': {'class': 'INDUSTRY', 'fullName': 'NovaBay Pharmaceuticals, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Efficacy Study of Auriclosene Irrigation Solution on Indwelling Urinary Catheter Patency', 'orgStudyIdInfo': {'id': 'CL1401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Auriclosene (AIS)', 'description': 'Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks', 'interventionNames': ['Drug: Auriclosene Irrigation Solution, 0.2%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Auriclosene Vehicle Solution', 'description': 'Auriclosene Vehicle Solution, 8 treatments over 4 weeks', 'interventionNames': ['Drug: Auriclosene Vehicle Solution']}], 'interventions': [{'name': 'Auriclosene Irrigation Solution, 0.2%', 'type': 'DRUG', 'armGroupLabels': ['Auriclosene (AIS)']}, {'name': 'Auriclosene Vehicle Solution', 'type': 'DRUG', 'armGroupLabels': ['Auriclosene Vehicle Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Los Amigos Research and Education Institute', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Long Beach Healthcare System', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '21117', 'city': 'Owings Mills', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Urology Research Associates', 'geoPoint': {'lat': 39.41955, 'lon': -76.78025}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Hospital and Medical Clinic', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Urology Center Research Institute', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Delaware Valley Urology, LLC', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '07052', 'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kessler Institute for Rehabilitation', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Urology Group of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'The Urological Institute of Northeastern NY', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'McKay Urology', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Eastern Urological Associates', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Peters Medical Research', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Great Lakes Medical Research', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'McGuire Veterans Affairs Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Dean Clinic', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Kathryn Najafi-Tagol, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NovaBay Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NovaBay Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}