Status:

COMPLETED

Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus

Lead Sponsor:

Solventum US LLC

Collaborating Sponsors:

3M

Conditions:

Staphylococcus Aureus

Eligibility:

All Genders

18+ years

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 microbiol...

Eligibility Criteria

Inclusion

  • Subjects 18 years of age or older, male or female and from any race or culture.
  • 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

  • Subjects who are on the nasal topical antibiotic Mupirocin (Bactroban® Nasal Ointment) within the last 4 weeks.
  • 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.

Key Trial Info

Start Date :

December 1 2006

Trial Type :

OBSERVATIONAL

End Date :

March 1 2007

Estimated Enrollment :

2000 Patients enrolled

Trial Details

Trial ID

NCT00406549

Start Date

December 1 2006

End Date

March 1 2007

Last Update

October 2 2024

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Hope Research Institute

Phoenix, Arizona, United States, 85017

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

3

Atlanta Institute for Medical Research

Decatur, Georgia, United States, 30030

4

Northwestern Univesity

Chicago, Illinois, United States, 60611

Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus | DecenTrialz