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Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment

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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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
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
U.S. FDA Resources


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.


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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Peter Lio, MD Northwestern Unviersity

Responsible Party: Dennis West, Professor in Dermatology and Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT00997139     History of Changes
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:
Anti-Bacterial Agents
Polymyxins
Neomycin
Polymyxin B
Bacitracin
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local