The Prevalence of Extend-Spectrum β-Lactamase (ESBL) Producing Isolates Among Common Enterobacteriaceae in Taiwan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01725841
First received: October 8, 2009
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

Resistance to broad-spectrum cephalosporins through the acquisition and expression of Extended-Spectrum β-lactamase (ESBL) among Enterobacteriacea is increasing. The clinical implications of ESBLs are extremely serious and sensitive diagnostic methods are urgently needed to guide therapy, monitor resistance development and implement intervention strategies. Conventionally, detection of expression of ESBLs was based on reduction of ceftazidime of cefotaxime MICs by ≥ 3 two fold dilutions in the presence of clavulanic acid. However, the use of the above method was limited to cover only some of the bacterial species, including predominantly E. coli and Klebsiella spp., or tested strains which were all transconjugants generated in vitro. ESBLs are now reported in a growing number of genera other than E. coli or Klebsiella spp., and Serratia marcescens.

Carbapenems, including ertapenem, imipenem and meropenem, are the drugs of choice used for severe ESBL-producing bacterial infections. Failure to detect ESBL at the presence of AmpC β-lactamase might result in an important clinical concern because 4th generation cephalosporins, which are stable to AmpC β-lactamase, is not a drug of choice for severe infections caused by ESBLs-producing isolates. Fluoroquinolone-resistance in ESBL-producing Enterobacteriacea is common. In this study, the investigators will use isolates of Enterobacteriacea collected from different hospitals (isolates offered by the Taiwan Surveillance of Antimicrobial Resistance [TSAR] program) to investigate the susceptibility of ertapenem and five other antimicrobial agents against ESBLs-producing Enterobacteriacea.


Condition
Enterobacteriaceae Infections

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: The Prevalence of Extend-Spectrum β-Lactamase (ESBL) Producing Isolates Among Common Enterobacteriaceae in Taiwan

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • To determine the prevalence of ESBL-producing among Enterobacteriaceae isolates in Taiwan [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

bacterial isolates


Enrollment: 300
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

ENTEROBACTERIACEAE FROM TSAR COLLECTION

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01725841

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shan-Chwen Chang, Ph.D. Vice President, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01725841     History of Changes
Other Study ID Numbers: 200809012R
Study First Received: October 8, 2009
Last Updated: November 8, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
To determine the prevalence of ESBL-producing among Enterobacteriaceae isolates in Taiwan
To determine the susceptibility of ertapenem and other antimicrobial agents against Enterobacteriaceae isolates with and without expression of ESBLs
To determine the molecular typing of the Enterobacteriaceae isolates with expression of ESBLs
To analyze the association between geographic area, hospital types against the antimicrobial susceptibility

Additional relevant MeSH terms:
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 20, 2014