Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus

Staphylococcus Aureus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406549
• Other study ID #: I2MS 05-010077
• Status: Completed
• Phase: N/A
• First received: November 30, 2006
• Last updated: March 7, 2007
• Start date: December 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2007
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Staphylococcus Aureus

Locations

Country	Name	City	State
France	Hospital Bichat	Paris
Germany	University of Muenster Hospital and Clinics	Muenster
Netherlands	Amphia Hospital	Breda
United States	Johns Hopkins University	Baltimore	Maryland
United States	Northwestern Univesity	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Atlanta Institute for Medical Research	Decatur	Georgia
United States	University of Iowa	Iowa City	Iowa
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Hope Research Institute	Phoenix	Arizona
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
3M

Countries where clinical trial is conducted

United States,  France,  Germany,  Netherlands,