Network on Antimicrobial Resistance in Staphylococcus Aureus

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00341913
First received: June 19, 2006
Last updated: June 18, 2008
Last verified: June 2008
  Purpose

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.


Condition
Staphylococcus Aureus

Study Type: Observational
Official Title: Network on Antimicrobial Resistance in Staphylococcus Aureus

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date: March 2000
Estimated Study Completion Date: June 2008
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00341913

Locations
United States, Virginia
MRL Pharmaceutical Services
Herndon, Virginia, United States, 20171-4603
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00341913     History of Changes
Other Study ID Numbers: 999900012, OH00-I-N012
Study First Received: June 19, 2006
Last Updated: June 18, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Research
Repository
Registry
Surveillance
Databases

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014