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

Primary Purpose

Infectious Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nozin® Nasal Sanitizer®

Placebo

About this trial

This is an interventional prevention trial for Infectious Disease focused on measuring nasal sanitizer®, S. aureus, general bacteria, nasal carriage, decolonization

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nozin® Nasal Sanitizer®

Phosphate-buffered saline

Arm Description

Non-antibiotic, alcohol-based antiseptic

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01861457

First Posted

May 20, 2013

Last Updated

April 7, 2015

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT01861457

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infectious Disease

Keywords

nasal sanitizer®, S. aureus, general bacteria, nasal carriage, decolonization

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nozin® Nasal Sanitizer®

Arm Type

Experimental

Arm Description

Non-antibiotic, alcohol-based antiseptic

Arm Title

Phosphate-buffered saline

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Other

Intervention Name(s)

Nozin® Nasal Sanitizer®

Other Intervention Name(s)

Nozin® Nasal Sanitizer® antiseptic

Intervention 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.

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sham

Intervention Description

The placebo preparation, utilized to account for the potential mechanical effects of the application process, was phosphate buffered saline (PBS).

Primary Outcome Measure Information:

Title

Treatment-associated Change in S. Aureus Colonization During a Typical 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.

Time Frame

10-hour work day

Secondary Outcome Measure Information:

Title

Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 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.

Time Frame

10 hour workday

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaun A Nguyen, MD

Organizational Affiliation

Medical University of South Carolina- Department of Otolaryngology - Head and Neck Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24881497

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.

Results Reference

result

Links:

URL

http://www.nozin.com

Description

Site containing information regarding the alcohol-based antiseptic preparation used

URL

http://www.nozinpro.com

Description

Site containing information regarding the alcohol-based antiseptic preparation used

Learn more about this trial

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

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