Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment
Primary Purpose
Nasal Carriers of Staphylococcus Aureus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Carriers of Staphylococcus Aureus focused on measuring healthcare, staphylococcus aureus, nasal
Eligibility Criteria
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
Sites / Locations
- Northwestern University
Outcomes
Primary Outcome Measures
Carrier Rate for Staphylococcus Aureus
Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)
MSSA Clearance Rate
Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.
MRSA Clearance Rate
Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT00997139
First Posted
October 15, 2009
Last Updated
December 11, 2014
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT00997139
Brief Title
Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment
Official Title
Clearance of Nasal Staphylococcus Aureus Colonization With Triple Antibiotic Ointment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Carriers of Staphylococcus Aureus
Keywords
healthcare, staphylococcus aureus, nasal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Carrier Rate for Staphylococcus Aureus
Description
Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)
Time Frame
Baseline
Title
MSSA Clearance Rate
Description
Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.
Time Frame
14 days
Title
MRSA Clearance Rate
Description
Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lio, MD
Organizational Affiliation
Northwestern Unviersity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
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Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment
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