- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01612182
The Incidence of Extended-spectrum β-lactamase (ESBL) Klebsiella Pneumonia in Patient on Renal Replacement Therapy
June 4, 2012 updated by: Hoseok Koo, Inje University
The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1289
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Je dong 2ga, Jung gu
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Seoul, Je dong 2ga, Jung gu, Korea, Republic of, 100-032
- Inje University Seoul Paik hospital Instituional Board Review
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patients had admitted in single center
Description
Inclusion Criteria:
- The age of patient was between 18 yrs and 79 yrs.
- The patient who showed Klebsiella pneumonia in 1st culture result of any site during hospitalization
Exclusion Criteria:
- The level of serum albumin was below 2.0 or over 5.0
- The level of AST or ALT was 2 times of normal level or the level of bilirubin was over 2.0 mg/dL during 1month.
- The level of Body mass index was below 15 or over 30
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ESBL(+) Klebsiella pneumonia
All the patient who's the culture result showed ESBL(+) Klebsiella pneumonia in any site during hospitalization
|
renal replacement therapy : hemodialysis and/or CRRT(continuous renal replacement therapy )
|
|
ESBL(-) Klebsiella pneumonia
All the patient who's the culture result showed ESBL(-) Klebsiella pneumonia in any site during hospitalization
|
renal replacement therapy : hemodialysis and/or CRRT(continuous renal replacement therapy )
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy
Time Frame: During hospitalization
|
The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy during hospitalization up to 8 years (from 2004 to 2011)
|
During hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The prevalence of ESBL Klebsiella pneumonia in patient with pneumonia and renal replacement therapy
Time Frame: during hospitalization
|
The prevalence of ESBL Klebsiella pneumoina in patient with pneumonia and renal replacement therapy during hospitalization up to 8 years (from 2004 to 2011)
|
during hospitalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
May 29, 2012
First Submitted That Met QC Criteria
June 4, 2012
First Posted (Estimate)
June 5, 2012
Study Record Updates
Last Update Posted (Estimate)
June 5, 2012
Last Update Submitted That Met QC Criteria
June 4, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESBL 2012-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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