Predictors of Rates of Resistant Gram-Negative Bacteria

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT01075009
Collaborator
(none)
36
1
38.9
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Study Details

Study Description

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 Intervention/Treatment Phase

    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; www.project-redcap.com) 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).

    Study Design

    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 :
    Feb 1, 2010
    Actual Primary Completion Date :
    May 1, 2013
    Actual Study Completion Date :
    May 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Relationship of ertapenem use and carbapenem resistant P. aeruginosa [2006-2011]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Aggregated data from adult inpatients
    Exclusion Criteria:
    • Children

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT01075009
    Other Study ID Numbers:
    • PT104983
    First Posted:
    Feb 24, 2010
    Last Update Posted:
    Jul 9, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Virginia Commonwealth University

    Study Results

    No Results Posted as of Jul 9, 2014