BacLite Rapid MRSA Clinical Performance

November 27, 2024 updated by: Solventum US LLC
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30030
        • Atlanta Institute for Medical Research, Inc.
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21201-1595
        • University of Maryland
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1042
        • Wake Forest University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solventum US LLC

Collaborators

3M

Investigators

  • Principal Investigator: Werner E Bischoff, Wake Forest University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

October 6, 2007

First Submitted That Met QC Criteria

October 6, 2007

First Posted (Estimated)

October 10, 2007

Study Record Updates

Last Update Posted (Actual)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 010737

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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