Network on Antimicrobial Resistance in Staphylococcus Aureus

June 30, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Herndon, Virginia, United States, 20171-4603
        • MRL Pharmaceutical Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 16, 2000

Study Completion

June 17, 2008

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

June 17, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999900012
  • OH00-I-N012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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