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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Carrier Rate for Staphylococcus Aureus | Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab) | Baseline |
| MSSA Clearance Rate | Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment. | 14 days |
| MRSA Clearance Rate | Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Lio, MD | Northwestern Unviersity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
Only subjects with a positive Baseline culture continued on a treatment arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Baseline culture positive for Staphylococcus aureus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Carrier Rate for Staphylococcus Aureus | Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab) | Posted | Number | percentage of subjects | Baseline |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Unit Coordinator | Northwestern University Department of Dermatology | 312-695-6829 | mandybrowning2015@u.northwestern.edu |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C001816 | bacitracin zinc, neomycin sulfate, polymyxin B, drug combination |
| D009355 | Neomycin |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | MSSA Clearance Rate | Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment. | Posted | Number | percentage of subjects | 14 days |
|
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|
| Primary | MRSA Clearance Rate | Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment. | Posted | Number | percentage of subjects | 14 days |
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| 0 |
| 216 |
| 0 |
| 216 |
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