Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus

Completed

• Conditions: Staphylococcus Aureus

• Registration Number: NCT00406549
• Lead Sponsor: Solventum US LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Study Start: 2006-12
• Study First Posted: 2006-12-04
• Study Completion: 2007-03
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (11)

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Amphia Hospital; 🇳🇱 Breda, Netherlands

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Atlanta Institute for Medical Research; 🇺🇸 Decatur, Georgia, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Northwestern Univesity; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Hope Research Institute; 🇺🇸 Phoenix, Arizona, United States

University of Muenster Hospital and Clinics; 🇩🇪 Muenster, Germany

Hospital Bichat; 🇫🇷 Paris, France