Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 12:41 AM
Study NCT ID:
NCT02835456
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2016-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-04-21', 'releaseDate': '2017-03-12'}], 'estimatedResultsFirstSubmitDate': '2017-03-12'}}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-01', 'studyFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2016-07-15', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)', 'timeFrame': '12 weeks', 'description': 'Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.'}, {'measure': 'Number of symptomatic Urinary tract infections (UTIs) determined by urine culture.', 'timeFrame': '12 weeks', 'description': 'Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.'}], 'secondaryOutcomes': [{'measure': 'Incidence of bacteremia', 'timeFrame': '12 weeks', 'description': 'Incidence of bacteremia following CA-SUTI'}, {'measure': 'Incidence of Crustation', 'timeFrame': '12 weeks', 'description': 'Incidence of catheter obstruction/encrustation requiring removal'}, {'measure': 'Incidence of Discomfort', 'timeFrame': '12 weeks', 'description': 'Incidence of significant discomfort/pain requiring removal'}, {'measure': 'Surface analysis of the type of bacteria found on each catheter', 'timeFrame': '12 weeks', 'description': 'Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of bacterial colonization'}, {'measure': 'Surface analysis of the amount of encrustation', 'timeFrame': '12 weeks', 'description': 'Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of encrustation'}, {'measure': 'Surface analysis of the biofilm formation', 'timeFrame': '12 weeks', 'description': 'Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of biofilm formation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CAUTI', 'Biofilm', 'Urinary tract infections', 'micropattern', 'Catheter'], 'conditions': ['Catheter Associated Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine if the Sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.', 'detailedDescription': 'The aim of this study is to determine if the Sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient requires a chronic indwelling Foley catheter for at least 3 days.\n* Catheters will not remain indwelling greater than 30 days at a time\n* Patient is more than 18 years of age\n* Patient is able to give informed consent\n* Patient is able to attend follow-up sessions\n\nExclusion Criteria:\n\n* Patient is less than 18 years of age\n* Patient is pregnant\n* Patient with a known allergy to silicone\n* Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter\n* Patient unable to accommodate the catheter\n* Patient has an active urinary tract infection (UTI) or other diagnosed infection that is untreated.\n* Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period\n* Patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage)\n* Patient is unable to feel and/or communicate their symptoms\n* Informed consent is unable to be obtained\n* Patient is unable or unwilling to comply with the study follow-up schedule\n* Patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis\n* Any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study'}, 'identificationModule': {'nctId': 'NCT02835456', 'acronym': 'SHARKLET', 'briefTitle': 'Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Jahn Ferenc South Pest Teaching Hospital'}, 'officialTitle': 'Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?', 'orgStudyIdInfo': {'id': 'RCSFC028514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Sharklet Catheter', 'description': 'Patient requiring indwelling urinary catheter will be randomised into Group A or Group B', 'interventionNames': ['Device: Sharklet Catheter insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Silicone Foley Catheter', 'description': 'Patient requiring indwelling urinary catheter will be randomised into Group A or Group B', 'interventionNames': ['Device: Silicone Foley Catheter insertion']}], 'interventions': [{'name': 'Sharklet Catheter insertion', 'type': 'DEVICE', 'armGroupLabels': ['Group A: Sharklet Catheter']}, {'name': 'Silicone Foley Catheter insertion', 'type': 'DEVICE', 'armGroupLabels': ['Group B: Silicone Foley Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1204', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Jahn Ferenc South Pest Teaching Hospital', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jahn Ferenc South Pest Teaching Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Urology', 'investigatorFullName': 'Prof. Peter Tenke', 'investigatorAffiliation': 'Jahn Ferenc South Pest Teaching Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-03-12', 'type': 'RELEASE'}, {'date': '2017-04-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Prof. Peter Tenke, Director, Department of Urology, Jahn Ferenc South Pest Teaching Hospital'}}}}