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

Community Acquired Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961206
• Other study ID #: SRRSH-ESBL01
• Status: Completed
• Phase: N/A
• First received: September 30, 2013
• Last updated: November 19, 2015
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Sir Run Run Shaw Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 960
• Est. completion date: September 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• older than 18 years old

• community-onset bacteremia

Exclusion Criteria:

• recent hospitalization within one month in any hospital

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacteremia
• Community Acquired Infection
• Community-Acquired Infections

Intervention

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

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jian-cang Zhou M.D.

Country where clinical trial is conducted

China, 

References & Publications (2)

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 — View Citation

Rodríguez-Baño J, Picón E, Gijón P, Hernández JR, Ruíz M, Peña C, Almela M, Almirante B, Grill F, Colomina J, Giménez M, Oliver A, Horcajada JP, Navarro G, Coloma A, Pascual A; Spanish Network for Research in Infectious Diseases (REIPI). Community-onset b — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors for community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae		one year	No