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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.
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
The study has one primary Specific Aim:
To 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.
A 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nozin® Nasal Sanitizer® | Experimental | Non-antibiotic, alcohol-based antiseptic |
|
| Phosphate-buffered saline | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nozin® Nasal Sanitizer® | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day | 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. | 10-hour work day |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day | 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. | 10 hour workday |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaun A Nguyen, MD | Medical University of South Carolina- Department of Otolaryngology - Head and Neck Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24881497 | Result | 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. |
| Label | URL |
|---|---|
| Site containing information regarding the alcohol-based antiseptic preparation used | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nozin® Nasal Sanitizer® | 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. |
| FG001 | Phosphate-buffered Saline (PBS) Placebo | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nozin Nasal Sanitizer | Apply 4 rotations of swab to each nostril 3x in a 10-hour study period. Nozin Nasal Sanitizer |
| BG001 | Saline Placebo | Apply 4 rotations of swab to each nostril 3x in a 10-hour study period. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day | 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. | All participants who received 3 scheduled treatments | Posted | Median | Inter-Quartile Range | Percent change in colonization | 10-hour work day |
|
Over the 10 hour period of applications
Serious: allergic symptoms; Other: nasal dryness, irritation, burning.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nozin Nasal Sanitizer | Apply 4 rotations of swab to each nostril every four hours Nozin Nasal Sanitizer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shaun A. Nguyen, MD, Associate Professor- Director of Clinical Research | Medical University of South Carolina | 8437921356 | nguyensh@musc.edu |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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|
|
| Placebo | Other | The placebo preparation, utilized to account for the potential mechanical effects of the application process, was phosphate buffered saline (PBS). |
|
|
| Site containing information regarding the alcohol-based antiseptic preparation used | View source |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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. |
|
|
|
| Secondary | Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day | 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. | Posted | Median | Inter-Quartile Range | Percent change in colonization | 10 hour workday |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Sham | Apply 4 rotations of swab to each nostril every four hours ... Sham | 0 | 19 | 0 | 19 |
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| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |