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Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997139
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : May 8, 2012
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nasal Carriers of Staphylococcus Aureus Drug: Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clearance of Nasal Staphylococcus Aureus Colonization With Triple Antibiotic Ointment
Study Start Date : September 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Intervention Details:
  • Drug: Neosporin (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.

Outcome Measures
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Primary Outcome Measures :
  1. Carrier Rate for Staphylococcus Aureus [ Time Frame: Baseline ]
    Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)

  2. MSSA Clearance Rate [ Time Frame: 14 days ]
    Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.

  3. MRSA Clearance Rate [ Time Frame: 14 days ]
    Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997139


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Peter Lio, MD Northwestern Unviersity
More Information
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Responsible Party: Dennis West, Professor in Dermatology and Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT00997139    
Other Study ID Numbers: NU-9892
First Posted: October 19, 2009    Key Record Dates
Results First Posted: May 8, 2012
Last Update Posted: January 5, 2015
Last Verified: December 2014
Keywords provided by Dennis West, Northwestern University:
healthcare
staphylococcus aureus
nasal
Additional relevant MeSH terms:
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Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Polymyxins
Neomycin
Bacitracin
 Polymyxin B
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local