Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 5:35 PM
Study NCT ID:
NCT03176394
Status:
TERMINATED
Last Update Posted:
2023-11-07
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)
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': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'trouble with enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-02', 'studyFirstSubmitDate': '2017-05-30', 'studyFirstSubmitQcDate': '2017-05-31', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine microorganisms DNA analysis', 'timeFrame': 'Up to 14 days', 'description': 'Change in microorganisms in the test group compared to the control group.'}, {'measure': 'Catheter microorganisms DNA analysis', 'timeFrame': 'Up to 14 days', 'description': 'Change in microorganisms in the test group compared to the control group.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Urinary Tract Infections (UTIs)', 'timeFrame': '14 days', 'description': 'Number of instances of clinically symptomatic UTI in the test versus the control group'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Foley, UTI, Biofilm, DNA'], 'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days) catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel (BLASTX) or SOC (McKesson Jelly) lubricated catheters. Urine and/or catheter DNA analysis will be obtained at catheter insertion, 2, 5, 7 and 14 days after catheterization.', 'detailedDescription': 'This is a 2-week, single-site, randomized controlled pilot study in adults requiring short-term \\< 14 days catheterization. Subjects will be randomized 1:1 to either the BLASTX or SOC lubricated catheters.\n\nUrine and catheter DNA analysis will be obtained at catheter insertion, 2 to 3 days after catheterization and at 5, 7 and 14 days if catheterization was indicated for either duration.\n\nInformed consent discussion will be completed, ICF will be signed, prior to any study procedures.\n\nSubjects will be included only if all of the inclusion criteria and none of the exclusion criteria have been met.\n\nAfter randomization, subjects will be followed, urine samples will be collected at each scheduled visit and the catheters will be collected upon removal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years or older\n2. Absence of symptomatic UTI\n3. Absence of upper/lower tract obstructions\n4. No known allergies to the study products\n5. Willing to comply with all study procedures and available for the duration of the study\n\nExclusion Criteria:\n\n1. 17 years or younger\n2. Symptomatic UTI\n3. Presence of upper/lower tract obstructions\n4. Known allergic reaction to the study products\n5. Unable to provide signed and dated informed consent form'}, 'identificationModule': {'nctId': 'NCT03176394', 'briefTitle': 'Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Next Science TM'}, 'officialTitle': 'Efficacy of Bladder Catheters Lubricated With a Biofilm Disruptive Gel, in Reducing Catheter-associated Bacteriuria (CAB) Compared to Standard of Care: A PILOT Clinical Trial', 'orgStudyIdInfo': {'id': 'CSP-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BLASTX Lubricated Catheter', 'description': 'Subjects for which catheterization is prescribed will be catheterized with a Foley lubricated with BLASTX. This gel lubricates with the same viscosity as McKesson Jelly and has a biofilm disruptive active ingredient.', 'interventionNames': ['Device: BLASTX Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'McKesson Jelly Lubricated Catheter', 'description': 'Subjects for which catheterization is prescribed will be catheterized with a Foley lubricated with McKesson Jelly. This jelly lubricates with the same viscosity as BLASTX but has no biofilm disruptive active ingredient.', 'interventionNames': ['Device: McKesson Jelly']}], 'interventions': [{'name': 'BLASTX Gel', 'type': 'DEVICE', 'description': 'Foley Catheter lubricated with BLASTX Gel', 'armGroupLabels': ['BLASTX Lubricated Catheter']}, {'name': 'McKesson Jelly', 'type': 'DEVICE', 'description': 'Foley Catheter lubricated with McKesson Jelly', 'armGroupLabels': ['McKesson Jelly Lubricated Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34747', 'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'facility': 'American Medical Research Institute', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}], 'overallOfficials': [{'name': 'Susan Greco, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Next Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Next Science TM', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}