Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus

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. Identifier: NCT00406549
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : March 8, 2007
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Brief Summary:
To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture methods.

Condition or disease
Staphylococcus Aureus

Study Type : Observational
Enrollment : 2000 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Multi-Center Clinical Performance Evaluation of a Rapid In Vitro Diagnostic Device for Direct Detection of Staphylococcus Aureus Nasal Colonization: Comparative Analysis to Culture Screening Methods
Study Start Date : December 2006
Study Completion Date : March 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects 18 years of age or older, male or female and from any race or culture.
  2. Subjects who are ambulatory (able to walk unaided or with a cane, walker, wheelchair) on the day of their pre-operative visit for non-emergent surgery.

Exclusion Criteria:

  1. Subjects who are on the nasal topical antibiotic Mupirocin (Bactroban® Nasal Ointment) within the last 4 weeks.
  2. Subjects who are present at the preoperative visit with prescribed nasal medical devices (e.g. CPAP = Continuous Positive Airway Pressure or Nasal Cannula), nasal prosthetics, the wearing of nasal jewelry or trauma to the nose or anything that may inhibit sampling of the anterior nares.

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 identifier (NCT number): NCT00406549

United States, Arizona
Hope Research Institute
Phoenix, Arizona, United States, 85017
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Georgia
Atlanta Institute for Medical Research
Decatur, Georgia, United States, 30030
United States, Illinois
Northwestern Univesity
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Hospital Bichat
Paris, France, 75877
University of Muenster Hospital and Clinics
Muenster, Germany, 48149
Amphia Hospital
Breda, Netherlands, 4818CK
Sponsors and Collaborators
Principal Investigator: Steve Gordon, M.D. The Cleveland Clinic Identifier: NCT00406549     History of Changes
Other Study ID Numbers: I2MS 05-010077
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: March 8, 2007
Last Verified: March 2007

Keywords provided by 3M:
Staphylococcus aureus
Nasal colonization
pre-surgical patients
Nasal Staphylococcus aureus in pre-surgical patients