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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 22, 2014