Official Title: “Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) Producing Bacteria”

This is an antibiotic intervention study to determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection.

Study Type: Interventional

Study Design: Health Services Research, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: Tazocin (pipercillin/tazobactam)
  • over 50% third generation cephalosporin should be replaced by Pip/Taz

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • baseline, collecting rectal swab samples
• Active Comparator: 2
  • use pipercill/tazobact to replace 3rd generation cephalosporin and collect rectal swab

Primary Measures

• 1. The acquisition rate of ESBL producing E. coli or K. Pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months of intervention phase)
  • Time Frame: 9 months
    Safety Issue?: No

Secondary Measures

• The infection rate due to ESBL producing E. coli or K. pnumoniae at the end of phase I (pre-intervention) and phase II (last 3 months of intervention phase)
  • Time Frame: 9 months
    Safety Issue?: No

Inclusion Criteria:

• All patients admitted or transferred to ICU/Pulmonary units
• Patients of either sex, 18 years of age or older

Exclusion Criteria:

• Patients who stay in units less than 48 hours will not be enrolled.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Overall Contact: Trial Manager  clintrialparticipation@wyeth.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00488189

Study ID Number: 0910X-102370

ClinicalTrials.gov Identifier: NCT00488189

Health Authority: China: State Food and Drug Administration