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CompletedNCT01075009Updated Jul 9, 2014

Predictors of Rates of Resistant Gram-Negative Bacteria

An observational study in Relationship of Carbapenem Use to Carbapenem Resistant Gram-negative Bacteria, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-09.

Sponsored by Virginia Commonwealth University · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
36
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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).

02

Conditions studied

  • Relationship of Carbapenem Use to Carbapenem Resistant Gram-negative Bacteria

Keywords

  • Antibiotics
  • Resistance
  • Epidemiology
  • Gram-negative bacteria
  • Epidemiology of antibiotic use
03

In context

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospitalized adult patients

Inclusion criteria

  • Aggregated data from adult inpatients

Exclusion criteria

Exclusion Criteria:

  • Children
05

Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
36 participants (actual)
06

What researchers measure

Primary outcomes

  1. Relationship of ertapenem use and carbapenem resistant P. aeruginosa

    Time frame: 2006-2011

07

Study locations

1 site
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
08

References and documents

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. PubMed 19001203 ↗
  • 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. PubMed 19273670 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01075009
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Feb 24, 2010
Start date
Feb 2010
Primary completion
May 2013
Completion
May 2013
Last update
Jul 9, 2014

Study contacts

Ron E Polk, Pharm.D.
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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