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

NCT ID: NCT01392118

Last Updated: 2011-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Bacteremia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Gung Medical Foundation, Kaohsiung Branch

Principal Investigators

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Chen-Hsiang Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Medical Foundation, Kaohsiung Branch

Locations

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Chang Gung Medical Foundation, Kaohsiung Branch

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Facility Contacts

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Chen-Hsiang Lee, M.D.

Role: primary

886-7-7317123 ext. 8304

Other Identifiers

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MISP38634

Identifier Type: -

Identifier Source: org_study_id

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