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

Purpose

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.

Condition	Intervention
Eluted Swab	Device: Eluted Swab


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Comparison of Elution Swab (ESwab) and Amies Transport Swabs for Screening Patients for Methicillin Resistant Staphylococcus Aureus (MRSA) and Vancomycin Resistant Enterococci (VRE) Colonization

Resource links provided by NLM:

MedlinePlus related topics: MRSA

Drug Information available for: Vancomycin

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	30
Study Start Date:	July 2009
Study Completion Date:	March 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
MRSA/VRE patients patients known to be colonized with MRSA/VRE	Device: Eluted Swab Comparison of Eluted Swab with AMIES swab for detection of MRSA/VRE

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Hospitalized patients known to be colonized with MRSA/VRE

Criteria

Inclusion Criteria:

Hospitallized patients known to be colonized with MRSA/VRE

Exclusion Criteria:

Unable to provide informed consent

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941122

Locations


Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6

Sponsors and Collaborators

Hamilton Health Sciences Corporation

McMaster University

St. Joseph's Healthcare Hamilton

Investigators


Principal Investigator:	Christine Lee, MD	McMaster University

More Information


Responsible Party:	Christine Lee, McMaster University
ClinicalTrials.gov Identifier:	NCT00941122 History of Changes
Other Study ID Numbers:	MRSA.VRE.Detection
Study First Received:	July 16, 2009
Last Updated:	July 19, 2011
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:


MRSA, VRE

Additional relevant MeSH terms:


Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Vancomycin	Methicillin Anti-Bacterial Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 27, 2016

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