BacLite Rapid MRSA Clinical Performance

This study has been terminated.

(performance variability)

Sponsor:

Information provided by:

ClinicalTrials.gov Identifier:

NCT00541632

First received: October 6, 2007

Last updated: May 14, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

October 6, 2007

Last Updated Date

May 14, 2008

Start Date ^ICMJE

October 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00541632 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

BacLite Rapid MRSA Clinical Performance

Official Title ^ICMJE

BacLite Rapid MRSA Clinical Performance

Brief Summary

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

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Methicillin Resistance

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Not Provided

Completion Date

March 2008

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00541632

Other Study ID Numbers ^ICMJE

010737

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Werner E Bischoff

Wake Forest University

Information Provided By

Verification Date

May 2008

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

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