Clinical trial NCT01861457: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Disease
Keywords: nasal sanitizer®
S. aureus
general bacteria
nasal carriage
decolonization
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day
timeFrame: 10-hour work day
Secondary outcomes:
measure: Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day
timeFrame: 10 hour workday
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina- Department of Otolaryngology - Head and Neck Surgery
name: Shaun A Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.