Predictors of Rates of Resistant Gram-Negative Bacteria
Information source: Virginia Commonwealth University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relationship of Carbapenem Use to Carbapenem Resistant Gram-negative Bacteria
Phase: N/A
Status: Completed
Sponsored by: Virginia Commonwealth University Official(s) and/or principal investigator(s):
Ron E Polk, Pharm.D., Principal Investigator, Affiliation: Virginia Commonwealth University
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.
Clinical Details
Official title: Predictors of Rates of Resistant Gram-Negative Bacteria in a Consortium of Academic Medical Center Hospitals.
Study design: Observational Model: Ecologic or Community, Time Perspective: Retrospective
Primary outcome: Relationship of ertapenem use and carbapenem resistant P. aeruginosa
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Aggregated data from adult inpatients
Exclusion Criteria:
- Children
Locations and Contacts
Virginia Commonwealth University, Richmond, Virginia 23298, United States
Additional Information
Related publications: Pakyz AL, MacDougall C, Oinonen M, Polk RE. Trends in antibacterial use in US academic health centers: 2002 to 2006. Arch Intern Med. 2008 Nov 10;168(20):2254-60. doi: 10.1001/archinte.168.20.2254. Pakyz AL, Oinonen M, Polk RE. Relationship of carbapenem restriction in 22 university teaching hospitals to carbapenem use and carbapenem-resistant Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2009 May;53(5):1983-6. doi: 10.1128/AAC.01535-08. Epub 2009 Mar 9.
Starting date: February 2010
Last updated: July 8, 2014
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