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
Recruitment status was Not yet recruiting
Sponsor:
Chang Gung Memorial Hospital
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
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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
Detailed Description:
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 |
-
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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
| 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 28, 2016