Network on Antimicrobial Resistance in Staphylococcus Aureus



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:March 2000
End Date:June 2008

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Reduced susceptibility of Staphyloccus aureus to the glycopeptide antibiotic vancomycin is
causing increasing concern worldwide in view of the threat of increased morbidity and
mortality caused by such resistant organisms. MRL Pharmaceutical Services, a Division of
Focus/MRL, has been contracted by NIAID to establish a Network on Antimicrobial Resistance
in S. aureus (NARSA) to document cases where staphylococcal isolates with reduced
susceptibility to vancomycin (MIC's greater than or equal to 4 micrograms/ml) have arisen
and to procure such isolates into a central repository for distribution to registered
approved researchers.

MRL will be responsible for contacting sites where such isolates have been reported to
discuss the test methods used to determine the reduced vancomycin susceptibility status of
the isolate. Once the MRL Laboratory has determined that the isolate meets the criteria
stated above, the site will be asked to ship the isolate to MRL as a possible candidate for
inclusion in the NARSA Repository. The procurement strategy will involve issuing each
isolate a temporary strain designation number which will be destroyed once the antibiotic
profile of the isolate has been confirmed at MRL, thus preventing any link to the data
generated by the site. The isolate and its antimicrobial susceptibility profile to several
key drugs will be recorded in the NARSA Repository database. Demographic information related
to the isolate and collected from the site includes: The Name of the Donor Site/Institution,
City (to be held in a separate secured database, these data points are not available to
registered user); State, Country of Donor Site; Isolation Date; Age; Sex; Patient Location;
Patient Service; Culture Source; Reporting History. This information will be held in the
Registry database. Since patient-specific information will not be collected, a request for a
waiver of informed consent has been requested herein.

NIAID funded investigators (NARSA Core Investigators) and other approved registered users
whose research focuses on S. aureus will have access to the Registry/Repository database and
will be able to request isolates for use in their research. Facility specific information
will be held in a separate secured database that is not available to registered researchers
unless approved through an IRB review.

Reduced susceptibility of Staphyloccus aureus to the glycopeptide antibiotic vancomycin is
causing increasing concern worldwide in view of the threat of increased morbidity and
mortality caused by such resistant organisms. MRL Pharmaceutical Services, a Division of
Focus/MRL, has been contracted by NIAID to establish a Network on Antimicrobial Resistance
in S. aureus (NARSA) to document cases where staphylococcal isolates with reduced
susceptibility to vancomycin (MIC's greater than or equal to 4 micrograms/ml) have arisen
and to procure such isolates into a central repository for distribution to registered
approved researchers.

MRL will be responsible for contacting sites where such isolates have been reported to
discuss the test methods used to determine the reduced vancomycin susceptibility status of
the isolate. Once the MRL Laboratory has determined that the isolate meets the criteria
stated above, the site will be asked to ship the isolate to MRL as a possible candidate for
inclusion in the NARSA Repository. The procurement strategy will involve issuing each
isolate a temporary strain designation number which will be destroyed once the antibiotic
profile of the isolate has been confirmed at MRL, thus preventing any link to the data
generated by the site. The isolate and its antimicrobial susceptibility profile to several
key drugs will be recorded in the NARSA Repository database. Demographic information related
to the isolate and collected from the site includes: The Name of the Donor Site/Institution,
City (to be held in a separate secured database, these data points are not available to
registered user); State, Country of Donor Site; Isolation Date; Age; Sex; Patient Location;
Patient Service; Culture Source; Reporting History. This information will be held in the
Registry database. Since patient-specific information will not be collected, a request for a
waiver of informed consent has been requested herein.

NIAID funded investigators (NARSA Core Investigators) and other approved registered users
whose research focuses on S. aureus will have access to the Registry/Repository database and
will be able to request isolates for use in their research. Facility specific information
will be held in a separate secured database that is not available to registered researchers
unless approved through an IRB review.

- INCLUSION AND EXCLUSION CRITERIA:

This study is concerned with the collection of data on the antimicrobial phenotypes of
bacterial isolates and not the patient(s) from which they were isolated. Therefore,
criteria for the inclusion or exclusion of patients does not apply.
We found this trial at
1
site
Herndon, Virginia 20171
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Herndon, VA
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