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CompletedNCT01961206Updated Nov 23, 2015

Community-Onset Bacteremia Due to ESBL Producing E.Coli or K.Pneumoniae in China: Prevalence, Risk Factors and Prognosis

An observational study in Community Acquired Infection, sponsored by Jian-cang Zhou M.D.. Completed at 1 site in China. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2015-11-23.

Sponsored by Jian-cang Zhou M.D. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
960
Ages
18 Years to 95 Years
Sex
All
01

Study summary

Escherichia coli is the leading cause of community-onset gram-negative bloodstream infections. There has been a dramatic increase in the prevalence of extended-spectrum b-lactamases producing E. coli and K.pneumoniae in the community, which was considered to be exclusively a nosocomial pathogen in recent years. As a result, the treatment options for community-onset infections due to ESBL-producing E. coli or K.pneumoniae are limited and the initial empirical therapy is often ineffective and associated with increased mortality. Although there were some reports of the risk factors of community-onset ESBL producing E. coli in Spain, Korea, and Canada, few empirical data were available about China. Therefore, the investigators aim was to investigate the epidemiology, risk factors, and the hospital outcomes for patients with community-onset bacteremia caused by ESBL producing E. coli or K.pneumoniae in China.

Read the detailed description

Eligibility criteria:

  1. Inclusion criteria:Blood cultures demonstrated E.coli or K.pneumoniae among nonhospitalized patients or within 48 h after hospitalization.
  2. Exclusion criteria:Patients with hospitalization in the past 1 month.

Outcome measures:

  1. Risk factors for community-onset bacteremia due to ESBL producing E. coli or K.pneumoniae
  2. Microbial and clinical efficacy of commonly used antibiotics for community-onset bacteremia due to ESBL producing E. coli or K.pneumoniae
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Conditions studied

  • Community Acquired Infection
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 960 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

This is the only study on the registry with Jian-cang Zhou M.D. as lead sponsor.

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

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All adult patients visited any of the 28 particitant hospitals during the study period were screened. Patients with community-onset bacteremia caused by E.coli or K. pneumoniae and without a recent hospitalization in any hospital will be included

Inclusion criteria

  • older than 18 years old
  • community-onset bacteremia

Exclusion criteria

Exclusion Criteria:

  • recent hospitalization within one month in any hospital
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
960 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Case Patients

    Case Patients with Community-Onset Bacteremia Due toESBL producing E.coli or K.pneumoniae

    Other: bacteremia caused by ESBL producing E.coli or K.pneumoniae

  • control group

    bacteremia caused by ESBL producing E.coli or K.pneumoniae

Interventions

  • Otherbacteremia caused by ESBL producing E.coli or K.pneumoniae

    community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae

06

What researchers measure

Primary outcomes

  1. Risk factors for community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae

    Time frame: one year

07

Study locations

1 site
  • Sir Run Run Shaw Hospital
    Hangzhou, Zhejiang 310016, China
08

References and documents

Publications

  • Rodriguez-Bano J, Picon E, Gijon P, Hernandez JR, Ruiz M, Pena C, Almela M, Almirante B, Grill F, Colomina J, Gimenez M, Oliver A, Horcajada JP, Navarro G, Coloma A, Pascual A; Spanish Network for Research in Infectious Diseases (REIPI). Community-onset bacteremia due to extended-spectrum beta-lactamase-producing Escherichia coli: risk factors and prognosis. Clin Infect Dis. 2010 Jan 1;50(1):40-8. doi: 10.1086/649537. PubMed 19995215 ↗
  • Apisarnthanarak A, Kiratisin P, Mundy LM. Predictors of mortality from community-onset bloodstream infections due to extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae. Infect Control Hosp Epidemiol. 2008 Jul;29(7):671-4. doi: 10.1086/588082. PubMed 18624669 ↗
  • Quan J, Zhao D, Liu L, Chen Y, Zhou J, Jiang Y, Du X, Zhou Z, Akova M, Yu Y. High prevalence of ESBL-producing Escherichia coli and Klebsiella pneumoniae in community-onset bloodstream infections in China. J Antimicrob Chemother. 2017 Jan;72(1):273-280. doi: 10.1093/jac/dkw372. Epub 2016 Sep 13. PubMed 27624571 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2015, 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
NCT01961206
Lead sponsor
Jian-cang Zhou M.D.
Responsible party
Jian-cang Zhou M.D. (Dr., Sir Run Run Shaw Hospital) — Sponsor-investigator
First posted
Oct 11, 2013
Start date
Oct 2013
Primary completion
Nov 2014
Completion
Sep 2015
Last update
Nov 23, 2015

Study contacts

Yun-song YU, M.D
principal investigator · Sir Run Run Shaw Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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