Study Evaluation Tazocin Intervention

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00488189
First received: June 18, 2007
Last updated: April 14, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Bacterial Infections
Drug: Tazocin (pipercillin/tazobactam)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
baseline, collecting rectal swab samples
Active Comparator: 2
use pipercill/tazobact to replace 3rd generation cephalosporin and collect rectal swab
Drug: Tazocin (pipercillin/tazobactam)
over 50% third generation cephalosporin should be replaced by Pip/Taz

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488189

Locations
China, Beijing
Beijing, Beijing, China, 100037
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For China, medinfo@wyeth.com
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier: NCT00488189     History of Changes
Other Study ID Numbers: 0910X-102370
Study First Received: June 18, 2007
Last Updated: April 14, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Bacterial Infections
Piperacillin
Piperacillin-tazobactam combination product
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014