Study Evaluation Tazocin Intervention

Verified by: Wyeth is now a wholly owned subsidiary of Pfizer, June 2010
First Received: June 18, 2007 | Last Updated: April 14, 2011 | Phase: Phase 4 | Start Date: May 2007
Overall Status: Completed | Estimated Enrollment: 134
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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...

Brief Summary

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: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
  • Study Primary Completion Date: February 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Wyeth is now a wholly owned subsidiary of Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00488189