Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus

NCT ID: NCT00406549

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Staphylococcus Aureus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steve Gordon, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hope Research Institute

Phoenix, Arizona, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Atlanta Institute for Medical Research

Decatur, Georgia, United States

Site Status

Northwestern Univesity

Chicago, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Hospital Bichat

Paris, , France

Site Status

University of Muenster Hospital and Clinics

Münster, , Germany

Site Status

Amphia Hospital

Breda, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States France Germany Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I2MS 05-010077

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.