NCT00724919

Brief Summary

To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, post- intervention in the selected medical centres

Trial Health

87
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2003

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

December 1, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
Last Updated

August 11, 2008

Status Verified

August 1, 2008

Enrollment Period

4 months

First QC Date

July 23, 2008

Last Update Submit

August 7, 2008

Conditions

Infection

Keywords

ESBL

Outcome Measures

Primary Outcomes (1)

  • The acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of surveillance phase

    48hours

Secondary Outcomes (1)

  • The infection rate due to ESBL producing E. coli, or due to K. pneumoniae at the end of surveillance phase

    48hours

Study Arms (1)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted to ICU/burn unit

You may qualify if:

  • All patients admitted or transferred to ICU/burn unit.
  • Patients were excluded if they had underlying conditions or diseases that were ultimately fatal within 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Miaoli County, 351, Taiwan

Location

Unknown Facility

Taichung, 40705, Taiwan

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 30, 2008

Study Start

December 1, 2003

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

August 11, 2008

Record last verified: 2008-08

Locations

TW(2)