Clinical trial NCT01961206: Community-Onset Bacteremia Due to ESBL Producing E.Coli or K.Pneumoniae in China: Prevalence, Risk Factors and Prognosis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Acquired Infection
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* older than 18 years old
* community-onset bacteremia

Exclusion Criteria:

* recent hospitalization within one month in any hospital

Primary outcomes:
measure: Risk factors for community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Yun-song YU, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.