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OpenTrials
Completed

NCT Number: NCT00406549

Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus

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.

Completed

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Key information

Conditions

Staphylococcus Aureus Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Hypersensitivity Immune System Diseases Infections Staphylococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Bichat, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Dec 4, 2006
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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