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

NCT01725841 | Completed DMC

• 1 other identifier: 200809012R
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Enterobacteriaceae Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To determine the prevalence of ESBL-producing among Enterobacteriaceae isolates in Taiwan

  3 months

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Biospecimen

Retention: NONE RETAINED

bacterial isolates

MeSH Terms

Conditions

Enterobacteriaceae Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Shan-Chwen Chang, Ph.D.

  Vice President, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: November 14, 2012
• Study Start: April 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

TW (1)