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Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN® Nasal Sanitizer® Antiseptic

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ClinicalTrials.gov Identifier: NCT01861457
Recruitment Status : Completed
First Posted : May 23, 2013
Results First Posted : April 22, 2015
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Infectious Disease Other: Nozin® Nasal Sanitizer® Other: Placebo

Detailed Description:

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN® Nasal Sanitizer®
Study Start Date : January 2013
Primary Completion Date : April 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Placebo
Other: Placebo
The placebo preparation, utilized to account for the potential mechanical effects of the application process, was phosphate buffered saline (PBS).
Other Name: Sham


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861457


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Shaun A Nguyen, MD Medical University of South Carolina- Department of Otolaryngology - Head and Neck Surgery
More Information

Additional Information:
Publications:
Responsible Party: Shaun A. Nguyen, Associate Professor- Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01861457     History of Changes
Other Study ID Numbers: Nozin
First Posted: May 23, 2013    Key Record Dates
Results First Posted: April 22, 2015
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Shaun A. Nguyen, Medical University of South Carolina:
nasal sanitizer®
S. aureus
general bacteria
nasal carriage
decolonization

Additional relevant MeSH terms:
Communicable Diseases
Infection
Anti-Infective Agents, Local
Anti-Infective Agents