NCT01392118

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 12, 2011

Status Verified

January 1, 2011

First QC Date

July 10, 2011

Last Update Submit

July 11, 2011

Conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adult patients (age\>=18 years) with at least one episode of ESBL-EK bloodstream infection from August 2004 to July 2010

You may not qualify if:

  • Patients who died within 48h after first episode of ESBL-EK bloodstream infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Medical Foundation, Kaohsiung Branch

Kaohsiung City, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

ESBL strains of E. coli or K. pneumoniae from blood cultures under normal practice

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chen-Hsiang Lee, M.D.

    Chang Gung Medical Foundation, Kaohsiung Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 10, 2011

First Posted

July 12, 2011

Study Start

July 1, 2011

Study Completion

December 1, 2012

Last Updated

July 12, 2011

Record last verified: 2011-01

Locations