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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Jian-cang Zhou M.D., Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier:
NCT01961206
First received: September 30, 2013
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Community Acquired Infection
Other: bacteremia caused by ESBL producing E.coli or K.pneumoniae

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Community-Onset Bacteremia Due to Extended-Spectrum β-Lactamase (ESBL)Producing Escherichia Coli or Klebsiella Pneumoniae in China: Prevalence, Risk Factors and Prognosis

Resource links provided by NLM:


Further study details as provided by Sir Run Run Shaw Hospital:

Primary Outcome Measures:
  • Risk factors for community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

bacterial strains


Estimated Enrollment: 840
Study Start Date: October 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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 wih hospitazation 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
  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • older than 18 years old
  • community-onset bacteremia

Exclusion Criteria:

  • recent hospitalization within one month in any hospital
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961206

Locations
China, Zhejiang
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310016
Sponsors and Collaborators
Jian-cang Zhou M.D.
Investigators
Principal Investigator: Yun-song YU, M.D Sir Run Run Shaw Hospital
  More Information

Publications:
Responsible Party: Jian-cang Zhou M.D., Dr., Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT01961206     History of Changes
Other Study ID Numbers: SRRSH-ESBL01
Study First Received: September 30, 2013
Last Updated: October 10, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Bacteremia
Community-Acquired Infections
Bacterial Infections
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 20, 2014