Nasal Carriers of Staphylococcus Aureus
Conditions
Keywords
healthcare, staphylococcus aureus, nasal
Brief summary
Staphylococcus aureus, a bacteria that lives commonly in the anterior nostrils, is seen in about 30% of healthcare workers. Applying mupirocin ointment, a prescription, to the nostrils twice daily for 5 days is the current standard of care for treatment to clear this bacteria. This research study is designed to determine the rate of clearance of this bacteria in healthcare workers who are carriers when using triple antibiotic ointment instead of mupirocin ointment.
Interventions
DRUGNeosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)
2 1/32oz packages will be dispensed. If positive nasal swab for S. aureus, subjects will apply a small amount to anterior nares twice daily for 5 days.
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to give informed consent * Must have consented prior to registration for the study
Exclusion criteria
* active infection * concurrent treatment with antibiotics, topical or systemic * S. aureus decolonization attempt in prior six months * history of HIV * chemotherapy or systemic immunosuppressive therapy * history of neomycin allergy or sensitivity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carrier Rate for Staphylococcus Aureus | Baseline | Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab) |
| MSSA Clearance Rate | 14 days | Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment. |
| MRSA Clearance Rate | 14 days | Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment. |
Countries
United States
Participant flow
Pre-assignment details
Only subjects with a positive Baseline culture continued on a treatment arm.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Baseline culture positive for Staphylococcus aureus | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 39.3 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 216 |
| serious Total, serious adverse events | 0 / 216 |
Outcome results
Primary
Carrier Rate for Staphylococcus Aureus
Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Carrier Rate for Staphylococcus Aureus | 20.8 percentage of subjects |
Primary
MRSA Clearance Rate
Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | MRSA Clearance Rate | 0 percentage of subjects |
Primary
MSSA Clearance Rate
Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | MSSA Clearance Rate | 57.1 percentage of subjects |