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

NCT01861457 | Completed Results

• 1 other identifier: Nozin
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day

  10 hour workday

Study Arms (2)

Nozin® Nasal Sanitizer®

EXPERIMENTAL

Non-antibiotic, alcohol-based antiseptic

Other: Nozin® Nasal Sanitizer®

Phosphate-buffered saline

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

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.

Also known as: Nozin® Nasal Sanitizer® antiseptic

Nozin® Nasal Sanitizer®

Placebo OTHER

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

Also known as: Sham

Phosphate-buffered saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 24881497 RESULT

Related Links

• Site containing information regarding the alcohol-based antiseptic preparation used
• Site containing information regarding the alcohol-based antiseptic preparation used

MeSH Terms

Conditions

Communicable Diseases; Staphylococcal Infections

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Results Point of Contact

• Title: Shaun A. Nguyen, MD, Associate Professor- Director of Clinical Research
• Organization: Medical University of South Carolina

nguyensh@musc.edu

8437921356

Study Officials

• Shaun A Nguyen, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor- Department of Otolaryngology - Head and Neck Surgery

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 23, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 2, 2024
• Results First Posted: April 22, 2015

Record last verified: 2024-09

Locations

US (1)