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Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus

This study has been completed.
Sponsor:
Information provided by:
3M
ClinicalTrials.gov Identifier:
NCT00406549
First received: November 30, 2006
Last updated: March 7, 2007
Last verified: March 2007

November 30, 2006
March 7, 2007
December 2006
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Complete list of historical versions of study NCT00406549 on ClinicalTrials.gov Archive Site
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Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus
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

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.

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Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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Staphylococcus Aureus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
March 2007
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Netherlands
 
NCT00406549
I2MS 05-010077
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3M
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Principal Investigator: Steve Gordon, M.D. The Cleveland Clinic
3M
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP