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

NCT ID: NCT01961206

Last Updated: 2015-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

960 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Community Acquired Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Case Patients

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

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

Intervention Type OTHER

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

control group

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

No interventions assigned to this group

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* older than 18 years old
* community-onset bacteremia

Exclusion Criteria

* recent hospitalization within one month in any hospital
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jian-cang Zhou M.D.

OTHER

Sponsor Role lead

Responsible Party

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Jian-cang Zhou M.D.

Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yun-song YU, M.D

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Locations

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Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 19995215 (View on PubMed)

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.

Reference Type RESULT
PMID: 18624669 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27624571 (View on PubMed)

Other Identifiers

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SRRSH-ESBL01

Identifier Type: -

Identifier Source: org_study_id