Recurrent ESBL-producing Enterobacteriaceae Bacteremia: Risk Factor, Molecular Character and Susceptibility Change

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Chang Gung Memorial Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01392118
First received: July 10, 2011
Last updated: July 11, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to investigate the risk factor, molecular character and susceptibility change for recurrent ESBL-producing Enterobacteriaceae bacteremia


Condition
Bacteremia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Recurrent ESBL-producing Enterobacteriaceae Bacteremia: Risk Factor, Molecular Character and Susceptibility Change

Further study details as provided by Chang Gung Memorial Hospital:

Biospecimen Retention:   Samples Without DNA

ESBL strains of E. coli or K. pneumoniae from blood cultures under normal practice


Estimated Enrollment: 400
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Detailed Description:
  1. To characterize the genotypes of the pathogens isolated from recurrent ESBL-EK bacteremia versus non-recurrent ESBL-EK bacteremia to differentiate relapse from reinfection

    • recurrent versus non-recurrent
    • relapse versus reinfection
  2. To correlate the patient characteristics, clinical manifestations, severity of illness (the modified Pitt bacteremia score), diagnosis of deep-site infection, co-morbid conditions (including diabetes mellitus, hepatic and renal dysfunction), length of stay in ICU/hospitalization, the presence of invasive procedures, source of pathogen (community acquired or nosocomial infection), antimicrobial regimen (i.e carbapenems versus non-carbapenems(flomoxef or quinolones), microbiological characteristics (E coli and Kleb. pneumoniae) and outcome endpoints (clinical outcome and mortality) with ESBL recurrence and genotypes
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

In a tertiary care hospital, every adult patient with at least one episode of ESBL-EK bloodstream infection from August 2004 to July 2010 will be recruited into this study. Patients who died within 48h after first episode of ESBL-EK bloodstream infection will be excluded.

Criteria

Inclusion Criteria:

  • Adult patients (age>=18 years) with at least one episode of ESBL-EK bloodstream infection from August 2004 to July 2010

Exclusion Criteria:

  • Patients who died within 48h after first episode of ESBL-EK bloodstream infection
  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: NCT01392118

Locations
Taiwan
Chang Gung Medical Foundation, Kaohsiung Branch Not yet recruiting
Kaohsiung, Taiwan
Contact: Chen-Hsiang Lee, M.D.    886-7-7317123 ext 8304    lee900@adm.cgmh.org.tw   
Principal Investigator: Chen-Hsiang Lee, M.D.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Chen-Hsiang Lee, M.D. Chang Gung Medical Foundation, Kaohsiung Branch
  More Information

No publications provided

Responsible Party: Chen-Hsiang Lee / Chief; Division of Infectious Diseases, Chang Gung Medical Foundation, Kaohsiung Branch
ClinicalTrials.gov Identifier: NCT01392118     History of Changes
Other Study ID Numbers: MISP38634
Study First Received: July 10, 2011
Last Updated: July 11, 2011
Health Authority: Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Disease Susceptibility
Bacteremia
Disease Attributes
Pathologic Processes
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on September 30, 2014