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NCT00941122 Clinical Trial

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

Eluted Swab Clinical Trial

— MRSA VRE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00941122
Other study ID # MRSA.VRE.Detection
Secondary ID
Status Completed
Phase N/A
First received July 16, 2009
Last updated July 19, 2011
Start date July 2009
Est. completion date March 2011

Study information
Verified date July 2011
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Hospitallized patients known to be colonized with MRSA/VRE

Exclusion Criteria:

- Unable to provide informed consent

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada St. Joseph's Healthcare Hamilton Ontario

Sponsors (3)
Lead Sponsor Collaborator
Hamilton Health Sciences Corporation McMaster University, St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1. To assess whether the Elution swab (ESwab) is superior to Amies transport swabs for the detection of MRSA/VRE 12 months No
Primary 1. To assess whether the Elution swab (ESwab) is superior to Amies transport swabs for the detection of MRSA/VRE in colonized patients 12 months No
Secondary 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. 12 months No