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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:

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

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
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

No publications provided

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
Methicillin
Vancomycin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013