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Study Evaluation Tazocin Intervention

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: NCT00488189
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : April 15, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Bacterial Infections Drug: Tazocin (pipercillin/tazobactam) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) Producing Bacteria
Study Start Date : May 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tazobactam
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier: NCT00488189     History of Changes
Other Study ID Numbers: 0910X-102370
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: June 2010

Additional relevant MeSH terms:
Bacterial Infections
Tazobactam
Piperacillin, tazobactam drug combination
Piperacillin
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action