Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment

December 11, 2014 updated by: Dennis West, Northwestern University

Clearance of Nasal Staphylococcus Aureus Colonization With Triple Antibiotic Ointment

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carrier Rate for Staphylococcus Aureus
Time Frame: Baseline
Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)
Baseline
MSSA Clearance Rate
Time Frame: 14 days
Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.
14 days
MRSA Clearance Rate
Time Frame: 14 days
Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Peter Lio, MD, Northwestern Unviersity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 16, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

January 5, 2015

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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