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NCT01392118 Clinical Trial

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

Bacteremia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01392118
Other study ID # MISP38634
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 10, 2011
Last updated July 11, 2011
Start date July 2011
Est. completion date December 2012

Study information
Verified date January 2011
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan : Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date December 2012
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Chang Gung Medical Foundation, Kaohsiung Branch Kaohsiung

Sponsors (2)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Taiwan, 

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