Clinical Trial: The Prevalence of Extend-Spectrum β-Lactamase (ESBL) Producing Isolates Among Common Enterobacteriaceae in Taiwan
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: The Prevalence of Extend-Spectrum β-Lactamase (ESBL) Producing Isolates Among Common Enterobacteriaceae in Taiwan
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.
Detailed Summary:
Materials and Methods
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Collection of bacterial isolates
The staffs in National Health Research Institute have established a long term surveillance of antimicrobial resistance from 22 to 44 hospitals distributed in all parts of Taiwan-Taiwan Surveillance of Antimicrobial Resistance (TSAR) since 1998. It has been conducted five times in year 1998, 2000, 2002, 2004, and 2006 and were named as TSAR-I, TSAR-II, TSAR-III, TSAR-IV and TSAR-V. In this study, isolates of Enterobacteriaceas from TSAR-IV will be recruited. Each 50 isolates of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae, Serratia marcescens, and Morganella morganii will be enrolled (about 10% of the TSAR IV collected isolates) for the following microbiological studies.
Isolates will be divided to ESBL-producing or non-producing groups by screening tests. All the available isolates were identified to the species or genus level by means of conventional methods. Isolates with same species recovered from the same an individual patient, are considered one isolate. The isolates were all stored at -70℃ in trypticase soy broth (Difco Laboratories, Detroit, MI) supplemented with 15% glycerol before being tested.
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Data Collection
Information collected for each isolate included: collection date, test date, identification, site of infection, hospital unit of the patient, and whether the isolate was acquired in the community (i.e., specimen obtained <48 hours after admission), the length of patient's hospital stay. The susceptibility of all the isolated against targeted antimi
Sponsor: National Taiwan University Hospital
Current Primary Outcome: To determine the prevalence of ESBL-producing among Enterobacteriaceae isolates in Taiwan [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Taiwan University Hospital
Dates:
Date Received: October 8, 2009
Date Started: April 2009
Date Completion:
Last Updated: November 8, 2012
Last Verified: November 2012
