Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-29 @ 1:06 AM
Study NCT ID:
NCT01861457
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2013-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN® Nasal Sanitizer® Antiseptic
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nguyensh@musc.edu', 'phone': '8437921356', 'title': 'Shaun A. Nguyen, MD, Associate Professor- Director of Clinical Research', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Over the 10 hour period of applications', 'description': 'Serious: allergic symptoms; Other: nasal dryness, irritation, burning.', 'eventGroups': [{'id': 'EG000', 'title': 'Nozin Nasal Sanitizer', 'description': 'Apply 4 rotations of swab to each nostril every four hours\n\nNozin Nasal Sanitizer', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham', 'description': 'Apply 4 rotations of swab to each nostril every four hours ...\n\nSham', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol-Based Nasal Antiseptic', 'description': 'Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-99.8', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-80.6'}, {'value': '-13.5', 'groupId': 'OG001', 'lowerLimit': '-69.3', 'upperLimit': '149.4'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '10-hour work day', 'description': 'The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.', 'unitOfMeasure': 'Percent change in colonization', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received 3 scheduled treatments'}, {'type': 'SECONDARY', 'title': 'Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol-Based Nasal Antiseptic', 'description': 'Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-91.0', 'groupId': 'OG000', 'lowerLimit': '-97.2', 'upperLimit': '-72.0'}, {'value': '24.0', 'groupId': 'OG001', 'lowerLimit': '-63.4', 'upperLimit': '74.6'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '10 hour workday', 'description': 'The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.', 'unitOfMeasure': 'Percent change in colonization', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nozin® Nasal Sanitizer®', 'description': 'Participants undergo three nasal vestibular applications of the alcohol-based antiseptic using a saturated nasal swab at 4-hour intervals during the 10-hour study period.'}, {'id': 'FG001', 'title': 'Phosphate-buffered Saline (PBS) Placebo', 'description': 'Participants undergo three nasal vestibular applications of the PBS placebo using a saturated nasal swab at 4-hour intervals during the 10-hour study period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants came from the nursing and technical staff working in the Main and Ambulatory operating rooms and patient care floors of the MUSC Hospital. Eligible to participate in the study were all healthy individuals between the ages of 18 and 70 years of age who were regular full-time employees working a minimum 10-hour workday.', 'preAssignmentDetails': 'Following the initial interview and after obtaining informed written consent, eligible subjects were screened to identify those who demonstrated nasal vestibular carriage of S. aureus. Subjects testing positive were invited to enroll in the study protocol within the subsequent 10 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nozin Nasal Sanitizer', 'description': 'Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.\n\nNozin Nasal Sanitizer'}, {'id': 'BG001', 'title': 'Saline Placebo', 'description': 'Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '64'}, {'value': '35.4', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '67'}, {'value': '35.1', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '67'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2013-05-20', 'resultsFirstSubmitDate': '2014-08-14', 'studyFirstSubmitQcDate': '2013-05-22', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-07', 'studyFirstPostDateStruct': {'date': '2013-05-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day', 'timeFrame': '10-hour work day', 'description': 'The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.'}], 'secondaryOutcomes': [{'measure': 'Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day', 'timeFrame': '10 hour workday', 'description': 'The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nasal sanitizer®', 'S. aureus', 'general bacteria', 'nasal carriage', 'decolonization'], 'conditions': ['Infectious Disease']}, 'referencesModule': {'references': [{'pmid': '24881497', 'type': 'RESULT', 'citation': 'Steed LL, Costello J, Lohia S, Jones T, Spannhake EW, Nguyen S. Reduction of nasal Staphylococcus aureus carriage in health care professionals by treatment with a nonantibiotic, alcohol-based nasal antiseptic. Am J Infect Control. 2014 Aug;42(8):841-6. doi: 10.1016/j.ajic.2014.04.008. Epub 2014 Jun 2.'}], 'seeAlsoLinks': [{'url': 'http://www.nozin.com', 'label': 'Site containing information regarding the alcohol-based antiseptic preparation used'}, {'url': 'http://www.nozinpro.com', 'label': 'Site containing information regarding the alcohol-based antiseptic preparation used'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the extent to which bacterial growth in the nostrils by S. aureus, a common bacteria that is found in hospital environment, can be reduced by NOZIN® Nasal Sanitizer® antiseptic nasal swabs during the course of a typical 10-hour work period in participants known to have S. aureus in their nose passages.', 'detailedDescription': 'The purpose of the proposed pilot study is to employ a repeated sampling protocol to test the effectiveness of a currently marketed, over-the-counter topical preparation to reduce carriage of Staphylococcus aureus (S. aureus) in the nasal vestibules of health professionals working in an outpatient clinical setting. The product to be tested is the NOZIN® Nasal Sanitizer® antiseptic produced by Global Life Technologies Corp. It is an alcohol-based, non-antibiotic antiseptic preparationl\n\nThe study has one primary Specific Aim:\n\nTo determine the extent to which colonization of the vestibular region of the nares by S. aureus can be reduced by a regimen of nasal topical applications of the alcohol-based antiseptic during the course of typical 10-hour work day in subjects known to exhibit S. aureus nasal carriage.\n\nA secondary aim of the study will be to evaluate the concurrent effectiveness of the antiseptic applications on a measure of general bacterial colonization within the vestibules of each subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All healthy health care professionals between the ages of 18 and 60 years of age who are regular full-time employees of the MUSC Hospital, work a 10 or 12 hour work shift, and test positive for nasal vestibular S. aureus carriage within 10 days prior to their scheduled study day will be eligible to participate in the study.\n\nExclusion Criteria:\n\n* Excluded from the study will be individuals exhibiting symptoms of upper respiratory disease, including chronic rhinitis/sinusitis, seasonal allergies, upper respiratory infection during the previous four weeks, have known allergy to citrus or soy oil, or are "smokers". "Non-smokers" will be defined as those individuals who have abstained from smoking for at least one year prior to the study. Subjects must be able and agree to refrain from using prescription and non-prescription nasal spray or other nasal preparations or washes from the time of their screening up to and during their scheduled study day.'}, 'identificationModule': {'nctId': 'NCT01861457', 'briefTitle': 'Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN® Nasal Sanitizer® Antiseptic', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN® Nasal Sanitizer®', 'orgStudyIdInfo': {'id': 'Nozin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nozin® Nasal Sanitizer®', 'description': 'Non-antibiotic, alcohol-based antiseptic', 'interventionNames': ['Other: Nozin® Nasal Sanitizer®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phosphate-buffered saline', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Nozin® Nasal Sanitizer®', 'type': 'OTHER', 'otherNames': ['Nozin® Nasal Sanitizer® antiseptic'], 'description': 'The treatment agent tested was the alcohol and natural oil preparation that comprises the commercially available over-the-counter (OTC) product, NOZIN® Nasal Sanitizer® antiseptic, by Global Life Technologies Corp, with the addition of benzalkonium chloride (0.13%), as described for the patented and safety-tested formulation.', 'armGroupLabels': ['Nozin® Nasal Sanitizer®']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Sham'], 'description': 'The placebo preparation, utilized to account for the potential mechanical effects of the application process, was phosphate buffered saline (PBS).', 'armGroupLabels': ['Phosphate-buffered saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Shaun A Nguyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina- Department of Otolaryngology - Head and Neck Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor- Department of Otolaryngology - Head and Neck Surgery', 'investigatorFullName': 'Shaun A. Nguyen, MD', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}