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Predictors of Rates of Resistant Gram-Negative Bacteria

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Virginia Commonwealth University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01075009
First received: February 23, 2010
Last updated: March 12, 2012
Last verified: February 2010
History of Changes
  Purpose

Antibiotic resistance in gram-negative bacteria continues to increase in US hospitals. This comes at a time when there are few new drugs in development that are active for these resistant organisms. The implication is that we must learn to use the drugs that we have more wisely and develop new strategies that will preserve existing agents. Antimicrobial "stewardship" programs are one strategy that many hospitals are adopting to improve the quality of antimicrobial use. The goal of this project is to develop a consortium of US academic medical centers that will allow characterization of the relationships between antibiotic use and rates of resistance for gram-negative pathogens, and to help hospital devise new strategies that will modify antibiotic use and possibly delay or reduce resistance.

The specific hypotheses are:

  • Hospitals with established or emerging resistance in gram-negative pathogens, including extended spectrum beta-lactamase (ESBL) producing organisms, carbapenem-resistant enterobacteriaceae (CRE)and carbapenem-resistant P. aeruginosa have a different pattern of antimicrobial drug use compared to hospitals with fewer of these organisms.
  • Hospital use of ertapenem is not associated with the rates of carbapenem-resistant organisms.

Condition
Bacteria
Epidemiology

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Predictors of Rates of Resistant Gram-Negative Bacteria in a Consortium of Academic Medical Center Hospitals.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized adult patients

Criteria

Inclusion Criteria:

  • Aggregated data from adult inpatients

Exclusion Criteria:

  • Children
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075009

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Ron E Polk, Pharm.D. Virginia Commonwealth University
  More Information

Publications:

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01075009     History of Changes
Other Study ID Numbers: PT104983
Study First Received: February 23, 2010
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Antibiotics
Resistance
Epidemiology
Gram=negative bacteria
Epidemiology of antibiotic use

ClinicalTrials.gov processed this record on May 16, 2013