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

Solventum US LLC11 sites in 4 countries2,000 target enrollmentDecember 2006

ConditionsStaphylococcus Aureus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Staphylococcus Aureus
Sponsor: Solventum US LLC
Enrollment: 2000
Locations: 11
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

March 2007

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Solventum US LLC

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.