The Incidence of Extended-spectrum β-lactamase (ESBL) Klebsiella Pneumonia in Patient on Renal Replacement Therapy

End-stage Renal Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612182
• Other study ID #: ESBL 2012-1
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: June 4, 2012
• Start date: March 2012
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1289
• Est. completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Other:
• renal replacement therapy
renal replacement therapy : hemodialysis and/or CRRT(continuous renal replacement therapy )

Locations

Country	Name	City	State
Korea, Republic of	Inje University Seoul Paik hospital Instituional Board Review	Seoul	Je dong 2ga, Jung gu

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy	The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy during hospitalization up to 8 years (from 2004 to 2011)	During hospitalization	No
Secondary	The prevalence of ESBL Klebsiella pneumonia in patient with pneumonia and renal replacement therapy	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	No