Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University
ClinicalTrials.gov Identifier:
NCT00997139
First received: October 15, 2009
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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 Intervention
Nasal Carriers of Staphylococcus Aureus
Drug: Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clearance of Nasal Staphylococcus Aureus Colonization With Triple Antibiotic Ointment

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Carrier Rate for Staphylococcus Aureus [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)

  • MSSA Clearance Rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.

  • MRSA Clearance Rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.


Enrollment: 216
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dennis West, Professor in Dermatology and Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT00997139     History of Changes
Other Study ID Numbers: NU-9892
Study First Received: October 15, 2009
Results First Received: April 10, 2012
Last Updated: April 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
healthcare
staphylococcus aureus
nasal

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Polymyxin B
Anti-Bacterial Agents
Bacitracin
Neomycin
Polymyxins
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Local
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014