Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-01 @ 11:38 AM
Study NCT ID:
NCT00990392
Status:
WITHDRAWN
Last Update Posted:
2015-05-29
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D055499', 'term': 'Catheter-Related Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006096', 'term': 'Gramicidin'}, {'id': 'D001414', 'term': 'Bacitracin'}, {'id': 'D010577', 'term': 'Petrolatum'}], 'ancestors': [{'id': 'D014449', 'term': 'Tyrothricin'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D052899', 'term': 'Pore Forming Cytotoxic Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Change of practice to antibiotic impregnated catheters and large study published showing their efficacy. Made topical antibiotics obselete.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-28', 'studyFirstSubmitDate': '2009-10-05', 'studyFirstSubmitQcDate': '2009-10-05', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall number of line related infections (local and blood borne)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Length of ICU stay', 'timeFrame': '7 months'}, {'measure': 'Length of hospital stay', 'timeFrame': '7 months'}, {'measure': 'Prevalence of methicillin-resistant Staphylococcus Aureus (MRSA)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blood stream infections', 'Catheter related infections', 'Central venous catheter related infections', 'Line sepsis', 'Topical antibiotics', 'Bacitracin', 'Polymixin', 'Gramicidin', 'Polysporin Triple Therapy', 'Intensive care unit'], 'conditions': ['Blood Stream Infections', 'Skin Diseases, Infectious']}, 'referencesModule': {'references': [{'pmid': '12506149', 'type': 'BACKGROUND', 'citation': 'Lok CE, Stanley KE, Hux JE, Richardson R, Tobe SW, Conly J. Hemodialysis infection prevention with polysporin ointment. J Am Soc Nephrol. 2003 Jan;14(1):169-79. doi: 10.1097/01.asn.0000038688.76195.a4.'}, {'pmid': '18413621', 'type': 'BACKGROUND', 'citation': 'James MT, Conley J, Tonelli M, Manns BJ, MacRae J, Hemmelgarn BR; Alberta Kidney Disease Network. Meta-analysis: antibiotics for prophylaxis against hemodialysis catheter-related infections. Ann Intern Med. 2008 Apr 15;148(8):596-605. doi: 10.7326/0003-4819-148-8-200804150-00004.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if the overall central venous catheter related infection rate can be reduced by the application of Polysporin Triple Therapy ointment to the insertion site.', 'detailedDescription': 'Previous studies in the dialysis population have found a reduction in local and system central venous catheter related infections with the application of topical antibiotics to the insertion point. One such study found a mortality benefit with Polysporin Triple Therapy ointment. We intend to determine if this preparation can reduce overall line infection rates in the ICU environment through its application at the time of line insertion and twice more the following week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients admitted to the ICU requiring a central venous catheter\n\nExclusion Criteria:\n\n* previous line infection during same ICU stay\n* CVC for hemodialysis'}, 'identificationModule': {'nctId': 'NCT00990392', 'acronym': 'ToPICL', 'briefTitle': 'Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections', 'organization': {'class': 'OTHER', 'fullName': 'Fraser Health'}, 'officialTitle': 'Pilot Study: Topical Antibiotics for Prevention of ICU Central Line Infections', 'orgStudyIdInfo': {'id': 'Kerrie-333333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polysporin Triple Therapy', 'description': 'Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week.', 'interventionNames': ['Drug: Polysporin Triple Therapy ointment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Petroleum jelly', 'interventionNames': ['Other: Petroleum Jelly']}], 'interventions': [{'name': 'Polysporin Triple Therapy ointment', 'type': 'DRUG', 'otherNames': ['Polysporin Triple Therapy (gramicidin, polymixin, bacitracin)'], 'description': 'Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week.', 'armGroupLabels': ['Polysporin Triple Therapy']}, {'name': 'Petroleum Jelly', 'type': 'OTHER', 'otherNames': ['Vaseline'], 'description': 'Petroleum jelly applied to the insertion point at the time of CVC placement and twice within the first week.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3L 1A1', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Royal Columbian Hospital', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}], 'overallOfficials': [{'name': 'Steven Reynolds, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fraser Health Authority'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fraser Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Critical care Physician', 'investigatorFullName': 'Steve Reynolds', 'investigatorAffiliation': 'Fraser Health'}}}}