Trial Outcomes & Findings for Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN® Nasal Sanitizer® Antiseptic (NCT NCT01861457)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

10-hour work day

Results posted on

2024-10-02

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Nozin® Nasal Sanitizer® Participants undergo three nasal vestibular applications of the alcohol-based antiseptic using a saturated nasal swab at 4-hour intervals during the 10-hour study period.	Phosphate-buffered Saline (PBS) Placebo Participants undergo three nasal vestibular applications of the PBS placebo using a saturated nasal swab at 4-hour intervals during the 10-hour study period.
Overall Study STARTED	20	19
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nozin Nasal Sanitizer n=20 Participants Apply 4 rotations of swab to each nostril 3x in a 10-hour study period. Nozin Nasal Sanitizer	Saline Placebo n=19 Participants Apply 4 rotations of swab to each nostril 3x in a 10-hour study period. Placebo	Total n=39 Participants Total of all reporting groups
Age, Continuous	34.5 years n=5 Participants	35.4 years n=7 Participants	35.1 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10-hour work day

Population: All participants who received 3 scheduled treatments

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.

Outcome measures

Outcome measures
Measure	Alcohol-Based Nasal Antiseptic n=20 Participants Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.	Placebo n=19 Participants Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.
Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day	-99.8 Percent change in colonization Interval -100.0 to -80.6	-13.5 Percent change in colonization Interval -69.3 to 149.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Alcohol-Based Nasal Antiseptic n=20 Participants Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.	Placebo n=19 Participants Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.
Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day	-91.0 Percent change in colonization Interval -97.2 to -72.0	24.0 Percent change in colonization Interval -63.4 to 74.6

Adverse Events

Nozin Nasal Sanitizer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shaun A. Nguyen, MD, Associate Professor- Director of Clinical Research

Medical University of South Carolina

Phone: 8437921356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place