Comparison of Elution Swab (ESwab) and Amies Transport Swabs for Screening Patients for Methicillin Resistant Staphylococcus Aureus (MRSA) and Vancomycin Resistant Enterococci (VRE) Colonization (MRSA VRE)

This study has been completed.

Sponsor:

Collaborators:

McMaster University

St. Joseph's Healthcare Hamilton

Information provided by:

McMaster University

ClinicalTrials.gov Identifier:

NCT00941122

First received: July 16, 2009

Last updated: July 19, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 16, 2009

Last Updated Date

July 19, 2011

Start Date ^ICMJE

July 2009

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

1. To assess whether the Elution swab (ESwab) is superior to Amies transport swabs for the detection of MRSA/VRE [ Time Frame: 12 months ] [ Designated as safety issue: No ]
1. To assess whether the Elution swab (ESwab) is superior to Amies transport swabs for the detection of MRSA/VRE in colonized patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00941122 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess patient comfort in the use of the ESwab vs. Amies Transport swab for screening patients for methicillin resistant Staphylococcus aureus and vancomycin-resistant Enterococcus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Elution Swab (ESwab) and Amies Transport Swabs for Screening Patients for Methicillin Resistant Staphylococcus Aureus (MRSA) and Vancomycin Resistant Enterococci (VRE) Colonization

Official Title ^ICMJE

Comparison of Elution Swab (ESwab) and Amies Transport Swabs for Screening Patients for Methicillin Resistant Staphylococcus Aureus (MRSA) and Vancomycin Resistant Enterococci (VRE) Colonization

Brief Summary

1.To assess whether the Elution swab (ESwab) is superior to Amies transport swabs for the detection of Methicillin Resistant Staphylococcus aureus (MRSA) and Vancomycin Resistant Enterococci (VRE) in colonized patients and to determine whether nasal cultures alone is sufficient for detection of MRSA isolates in hospitalized patients. 2.To assess patient comfort in the use of the ESwab vs. Amies Transport swab for screening patients for methicillin resistant Staphylococcus aureus and vancomycin-resistant Enterococcus.

Detailed Description

MRSA is a major cause of nosocomial and life threatening infections. Infections with MRSA have been associated with a significantly higher morbidity, mortality and costs than methicillin-susceptible S. aureus (MSSA).1 Selection of these organisms has been greatest in the healthcare setting; however, MRSA have also become more prevalent in the community.2 To control the transmission of MRSA, the Society for Healthcare Epidemiology of America (SHEA) has recommended guidelines, which include an active surveillance program to identify potential reservoirs and a rigorous infection control program to control the spread of MRSA. Accurate identification of patients colonized with MRSA is essential in managing the transmission of the organism. It is currently unknown whether the currently utilized collection rayon swab is the optimal swab in detecting colonized patients The purpose of this study is to directly compare whether Eluted (ESwab) swab is superior to the currently utilized rayon swab in identifying MRSA/VRE colonized patients.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients known to be colonized with MRSA/VRE

Condition ^ICMJE

Eluted Swab

Intervention ^ICMJE

Device: Eluted Swab

Comparison of Eluted Swab with AMIES swab for detection of MRSA/VRE

Study Group/Cohort (s)

MRSA/VRE patients

patients known to be colonized with MRSA/VRE

Intervention: Device: Eluted Swab

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

Completed

Enrollment ^ICMJE

Completion Date

March 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Hospitallized patients known to be colonized with MRSA/VRE

Exclusion Criteria:

Unable to provide informed consent

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00941122

Other Study ID Numbers ^ICMJE

MRSA.VRE.Detection

Has Data Monitoring Committee

Responsible Party

Christine Lee, McMaster University

Study Sponsor ^ICMJE

Hamilton Health Sciences Corporation

Collaborators ^ICMJE

McMaster University
St. Joseph's Healthcare Hamilton

Investigators ^ICMJE

Principal Investigator:

Christine Lee, MD

McMaster University

Information Provided By

McMaster University

Verification Date

July 2011

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

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