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Predictors of Rates of Resistant Gram-Negative Bacteria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01075009
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : July 9, 2014
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:

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 or disease
Relationship of Carbapenem Use to Carbapenem Resistant Gram-negative Bacteria

Detailed Description:

Antibacterial drug use

Systemic antibacterial drug use in adult inpatients discharged between January 1, 2006 and December 31, 2010 was obtained from patient-level billing records. These data were aggregated and reported for each hospital as days of therapy per 1000 patient days (DOT/1000PD) as previously described [10]. Any dose of an antibiotic received by a patient during a 24 hour period is counted as one DOT. For example, administration of imipenem/cilastatin 1000 mg every 8 hours, or administration of 500mg every 6 hours, is counted as one DOT. We have recently reported advantages of measuring antibiotic use by DOTs versus the metric usually recommended, the Defined Daily Dose (DDD) [12].

Antimicrobial susceptibility

In year 2009 we requested the annual cumulative hospital antibiograms from the 50 hospitals for the years in which we had carbapenem drug use. The contact at each hospital was usually the antimicrobial stewardship pharmacist, but may also have included the infectious diseases physician(s), clinical microbiologist or infection control practitioner. We utilized antibiograms with a full calendar year of susceptibility reported for all clinical isolates (at least 30 isolates), the total number of isolates and the proportion of resistant isolates.

All hospitals received an on-line survey requesting additional information regarding susceptibility testing methods and antibiogram construction. We used the secure survey instruments provided by REDCap (Research electronic data capture; to send and compile survey responses. Specifically we inquired about the inclusion/exclusion of duplicate clinical isolates in the antibiogram, method(s) of susceptibility testing, policy regarding surveillance cultures and we attempted to verify that Clinical Laboratory Standards Institute (CLSI) interpretative breakpoints were used for all years. As recommended by Schwaber we recorded both proportions and rates of carbapenem resistant P. aeruginosa [13]. The resistant proportion was the number of resistant isolates divided by total number of isolates, and the resistant incidence rate was the number of resistant isolates per 1000 adult patient days (PD).

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Study Type : Observational
Actual Enrollment : 36 participants
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.
Study Start Date : February 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Primary Outcome Measures :
  1. Relationship of ertapenem use and carbapenem resistant P. aeruginosa [ Time Frame: 2006-2011 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized adult patients

Inclusion Criteria:

  • Aggregated data from adult inpatients

Exclusion Criteria:

  • Children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01075009

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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
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Principal Investigator: Ron E Polk, Pharm.D. Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University Identifier: NCT01075009    
Other Study ID Numbers: PT104983
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014
Keywords provided by Virginia Commonwealth University:
Gram-negative bacteria
Epidemiology of antibiotic use