Infectious Disease
Conditions
Keywords
nasal sanitizer®, S. aureus, general bacteria, nasal carriage, decolonization
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.
Interventions
OTHERNozin® 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.
OTHERPlacebo
The placebo preparation, utilized to account for the potential mechanical effects of the application process, was phosphate buffered saline (PBS).
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day | 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. |
Countries
United States
Participant flow
Recruitment details
Participants came from the nursing and technical staff working in the Main and Ambulatory operating rooms and patient care floors of the MUSC Hospital. Eligible to participate in the study were all healthy individuals between the ages of 18 and 70 years of age who were regular full-time employees working a minimum 10-hour workday.
Pre-assignment details
Following the initial interview and after obtaining informed written consent, eligible subjects were screened to identify those who demonstrated nasal vestibular carriage of S. aureus. Subjects testing positive were invited to enroll in the study protocol within the subsequent 10 days.
Participants by arm
| Arm | Count |
|---|---|
| Nozin Nasal Sanitizer Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.
Nozin Nasal Sanitizer | 20 |
| Saline Placebo Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.
Placebo | 19 |
| Total | 39 |
Baseline characteristics
| Characteristic | Nozin Nasal Sanitizer | Saline Placebo | Total |
|---|---|---|---|
| Age, Continuous | 34.5 years | 35.4 years | 35.1 years |
| Sex: Female, Male Female | 20 Participants | 14 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
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.
Time frame: 10-hour work day
Population: All participants who received 3 scheduled treatments
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alcohol-Based Nasal Antiseptic | Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day | -99.8 Percent change in colonization |
| Placebo | Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day | -13.5 Percent change in colonization |
p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 10 hour workday
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alcohol-Based Nasal Antiseptic | Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day | -91.0 Percent change in colonization |
| Placebo | Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day | 24.0 Percent change in colonization |
p-value: <0.01Wilcoxon (Mann-Whitney)