Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN® Nasal Sanitizer® Antiseptic
|ClinicalTrials.gov Identifier: NCT01861457|
Recruitment Status : Completed
First Posted : May 23, 2013
Results First Posted : April 22, 2015
Last Update Posted : April 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Infectious Disease||Other: Nozin® Nasal Sanitizer® Other: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN® Nasal Sanitizer®|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||May 2013|
Experimental: Nozin® Nasal Sanitizer®
Non-antibiotic, alcohol-based antiseptic
Other: Nozin® Nasal Sanitizer®
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.
Other Name: Nozin® Nasal Sanitizer® antiseptic
Placebo Comparator: Phosphate-buffered saline
The placebo preparation, utilized to account for the potential mechanical effects of the application process, was phosphate buffered saline (PBS).
Other Name: Sham
- Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day [ Time Frame: 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.
- Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day [ Time Frame: 10 hour workday ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861457
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Shaun A Nguyen, MD||Medical University of South Carolina- Department of Otolaryngology - Head and Neck Surgery|