IRB SCC mec Typing Project

A.                                                        APPLICATION FORM

 

1. TITLE

            Genetic Lineage Tracking of Community and Hospital Acquired Methicillin        Resistant Staphylococcus aureus through SCCmec Typing

 

2. DESCRIPTION OF THE STUDY

We will be performing genetic testing on isolates of Staphylococcus aureus that LDS Hospital Microbiology has collected and frozen them since 1999.  No patient contact from which the isolates collected will be made. 

3. DURATION OF THE STUDY

            It is estimated that we will be collecting and correlating data from November      2005-April 2006.                                                                                            

4. MULTICENTER STUDY

All Laboratory testing will be performed in the Microbiology, and Molecular Pathology departments of LDS Hospital in Salt Lake City, UT.  Correlation projects will be conducted at both LDS Hospital, and Weber State University in the Clinical Laboratory Sciences department in Ogden, UT.

5. NUMBER OF SUBJECTS

We will be performing testing on approximately 200 previously isolated and frozen specimens.

6. HEALTH STATUS OF THE SUBJECTS

            All the isolates have come from patients that have sought medical attention due to           a Staphylococcal infection.

7. SUBJECT GROUPS EXCLUDED

            No specimens have been excluded for any purpose.  Only Staphylococcus aureus       isolates are being tested.

8. AGES OF THE SUBJECTS

            The study will include isolates from patients of all ages.

9. DESIGN OF THE STUDY

            The study will be a case control.

10. RISKS TO SUBJECTS  

            None, the specimens are frozen isolates of S. aureus.  There is no patient contact          involved.

ANY MODERATE OR HIGH RISK STUDY MUST GO THROUGH A SEPARATE REVIEW PROCEDURE WHICH INCLUDES THE APPROPRIATE ADMINISTRATIVE OFFICER AND THE UNIVERSITY ATTORNEY.

11. BENEFITS TO SUBJECTS AND OTHERS

Upon completion and correlation of the study set forth, this information will provide an extremely beneficial epidemiological tool for disease control within the hospital and community. 

12. COSTS TO BE BORNE BY SUBJECTS

            The participants will not be required to bear any costs.

13.  IS CONFIDENTIALITY ASSURED

No patient data is attached to the isolated specimens that will be tested, therefore team members will have no access to patient data.  It should also be noted that team members will receive IRB training through LDS Hospital as well already completing IRB training through Weber State University.

14. CONTRACT OR GRANT NUMBER

The team members have applied for funding through the University Undergraduate Research Committee.  LDS Hospital will supply additional funding as necessary

 15.  NAME OF PRINCIPAL INVESTIGATOR AND DEPARTMENT

The investigator is Travis Price of the Clinical Laboratory Sciences Department at WSU.

 

 

 

B.                                            DESCRIPTION OF THE STUDY

 

Abstract:

Methicillin Resistant Staphylococcus aureus (MRSA) has become a serious concern in the medical community in recent years. MRSA’s virulence and resistance to antibiotics leads to difficulty in treating infections, lengthy hospital stays, high medical costs, and an increase in patient mortality. In this project, we will categorize MRSA isolates according to their Staphylococcus Cassette Chromosome mec (SCCmec) type, presence of the Panton-Valentine Leukocidin (PVL) gene and antimicrobial susceptibility.

 

Introduction:

 

MRSA can be categorized into two groups, Community (CA-MRSA) and Hospital aquired (HA-MRSA) MRSA according to where the infection was contracted.  Therefore both hospitalized patients and healthy individuals are at risk.  In order to better understand the virulence of staphylococcal strains, genetic testing on the bacteria has been performed.  Two genes seem to play a significant role in the virulence of this organism.  These genes are known as the Panton-Valentine Leukocidin (PVL), and the Staphylococcal Cassette Chromosome mec (SCCmec) genes.  A previous study done by Weber State University students illustrated a correlation between the presence of the PVL gene in a strain, and that bacteria’s antibiotic resistance.  The SCCmec gene we will study codes for one of the five cassette types that the bacterium contains.  These cassette types allow for genetic tracking of certain MRSA strains and have been known to be indigenous to certain geographical locations

 

Our goal is to type the MRSA isolates according to their SCCmec genetic information. This will allow us to track the specific strains of MRSA, and thereby distinguish the genetic mutations of the SCCmec gene in CA-MRSA versus HA-MRSA. After completing this typing we will create a database in which our data will be added to the previous study’s information on PVL and antibiotic resistance. This database will provide tracking, perhaps in a hospital setting, to determine where a specific virulent strain may have originated and where it was introduced.  This assay will provide an extremely beneficial epidemiological tool for infection control within the hospital and community. 

 

The findings of our research project will be presented at a minimum of two venues: the Weber State University Undergraduate Research Symposium in March and the Utah Society of Clinical Laboratory Scientists Spring Seminar in April. We will also submit our project to the National Undergraduate Research Symposium.  Our team will submit our research reports for publication to various medical journals.

 

Our team will perform research and data collection independently in LDS hospital’s Microbiology and Molecular laboratory.  We will report to our Weber State University faculty mentor weekly.

 

All team members are seniors in the Clinical Laboratory Science program at Weber State University and are ASCP certified Medical Laboratory Technicians.  Two members are currently employed at LDS hospital in the Microbiology and Chemistry departments as Medical Laboratory Technicians.  The other team member is employed at Ogden Regional Medical Center as a Medical Laboratory Technician.

 

 

Methods and Materials:

 

We will perform DNA extraction, using the Qiagen method, on a 200 Staphylococcus aureus isolates, collected and frozen at LDS hospital since 1999.  After extraction the MRSA samples cassette types be determined by using real time PCR (rt-PCR) with established primers and probes on the Roche Lightcycler.  The cost of testing each isolate for the cassette type using this PCR assay will be four to six dollars.

 

Laboratory work will begin in November of 2005 and will continue till February of 2006.  Data that has been collected during that time will be analyzed from February to April of 2006 to determine correlation.  During this time we will also be preparing to present our data at the Weber State University symposium and at the USCLS Spring Seminar, and compiling a journal article to submit for publication in a scholarly journal.  

 


Weber State UniversityOgden, Utah 84408

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