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
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Condition or disease |
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Bacteremia |
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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
- 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 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 |

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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 |
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

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
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. |
Principal Investigator: | Chen-Hsiang Lee, M.D. | Chang Gung Medical Foundation, Kaohsiung Branch |
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 |