Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00724919
Previous Study | Return to List | Next Study

A Post-Intervention Surveillance Study Regarding the Acquisition Rate of ESBL-KP, Ecoli

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00724919
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : August 11, 2008
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date July 23, 2008
First Posted Date July 30, 2008
Last Update Posted Date August 11, 2008
Study Start Date December 2003
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 25, 2008)
The acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of surveillance phase [ Time Frame: 48hours ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 25, 2008)
The infection rate due to ESBL producing E. coli, or due to K. pneumoniae at the end of surveillance phase [ Time Frame: 48hours ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Post-Intervention Surveillance Study Regarding the Acquisition Rate of ESBL-KP, Ecoli
Official Title Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) (A Post-Intervention Surveillance Study)
Brief Summary To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, post- intervention in the selected medical centres
Detailed Description This is post-interventional study to follow the acquisition rate of ESBP producing E. coli or K. pneumoniae at the sites involved in a previous interventional study.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients admitted to ICU/burn unit
Condition Infection
Intervention Not Provided
Study Groups/Cohorts 1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 25, 2008)
256
Original Actual Enrollment Same as current
Actual Study Completion Date April 2004
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion

  1. All patients admitted or transferred to ICU/burn unit.
  2. Patients of either sex, 18 years of age or older. Exclusion

Patients were excluded if they had underlying conditions or diseases that were ultimately fatal within 48 hours

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00724919
Other Study ID Numbers 0910X-101440
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2008