Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment - Full Text View

Sponsor:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00997139

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:

MedlinePlus related topics: Antibiotics

Drug Information available for: Statrol Neomycin palmitate Neocidin Neomycin Polymyxin B Neomycin sulfate Polymyxin B Sulfate Bacitracin Bacitracin zinc Neosporin

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

The primary objective of this study is to determine the success rate of triple antibiotic ointment in eradicating S. aureus from the nares [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective of this study is to assess the success rate of triple antibiotic ointment in eradicating S. aureus compared to mupirocin ointment. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
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:

2 1/32oz packages will be distributed. 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

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:	Peter Lio, MD, Northwestern University
ClinicalTrials.gov Identifier:	NCT00997139 History of Changes
Other Study ID Numbers:	NU-9892
Study First Received:	October 15, 2009
Last Updated:	May 25, 2011
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
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012