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

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ClinicalTrials.gov Identifier: NCT01392118
Recruitment Status : Unknown
Verified January 2011 by Chang Gung Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 12, 2011
Last Update Posted : July 12, 2011
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Chang Gung Memorial Hospital

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to investigate the risk factor, molecular character and susceptibility change for recurrent ESBL-producing Enterobacteriaceae bacteremia

Condition or disease
Bacteremia

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

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Recurrent ESBL-producing Enterobacteriaceae Bacteremia: Risk Factor, Molecular Character and Susceptibility Change
Study Start Date : July 2011
Estimated Study Completion Date : December 2012
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples Without DNA
ESBL strains of E. coli or K. pneumoniae from blood cultures under normal practice

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: January 2011

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