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

November 19, 2015 updated by: Jian-cang Zhou M.D.

Community-Onset Bacteremia Due to Extended-Spectrum β-Lactamase (ESBL)Producing Escherichia Coli or Klebsiella Pneumoniae in China: Prevalence, Risk Factors and Prognosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

960

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • older than 18 years old
  • community-onset bacteremia

Exclusion Criteria:

  • recent hospitalization within one month in any hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae
control group
bacteremia caused by ESBL producing E.coli or K.pneumoniae

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Risk factors for community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jian-cang Zhou M.D.

Investigators

  • Principal Investigator: Yun-song YU, M.D, Sir Run Run Shaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (Estimate)

October 11, 2013

Study Record Updates

Last Update Posted (Estimate)

November 23, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRRSH-ESBL01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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