BacLite Rapid MRSA Clinical Performance

NCT ID: NCT00541632

Last Updated: 2024-12-02

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

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Recruitment Status

TERMINATED

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-03-31

Brief Summary

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The purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA test system to traditional culture methods in detecting the presence of Methicillin Resistant Staphylococcus aureus (MRSA) directly from nasal samples.

Detailed Description

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Conditions

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Methicillin Resistance

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subjects 18 years or older
* Subjects willing to document demographic characteristics
* Subjects willing to have their nose swabbed
* Subjects (or legal representative) willing to sign consent and authorization forms

Exclusion Criteria

* Subjects who use Vicks Sinex Nasal spray or other nasal sprays
* Subjects with prescribed nasal medical devices where collecting samples may resent more than minimal risk to subjects
* Subjects having nasal prosthetics, jewelry or trauma to the nose or anything that may prevents sampling the anterior nares
* Investigator believes that subject is unsuitable for inclusion.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Werner E Bischoff

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University

Locations

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Denver Health Medical Center

Denver, Colorado, United States

Site Status

Atlanta Institute for Medical Research, Inc.

Atlanta, Georgia, United States

Site Status

Evanston Northwestern Healthcare

Evanston, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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010737

Identifier Type: -

Identifier Source: org_study_id