Back to resultsStudy Evaluation Tazocin Intervention
Primary Purpose
Bacterial Infections
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tazocin (pipercillin/tazobactam)
Sponsored by
About this trial
This is an interventional health services research trial for Bacterial Infections
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
1
2
Arm Description
baseline, collecting rectal swab samples
use pipercill/tazobact to replace 3rd generation cephalosporin and collect rectal swab
Outcomes
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)
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)
Full Information
NCT ID
NCT00488189
First Posted
June 18, 2007
Last Updated
April 14, 2011
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00488189
Brief Title
Study Evaluation Tazocin Intervention
Official Title
Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) Producing Bacteria
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
baseline, collecting rectal swab samples
Arm Title
2
Arm Type
Active Comparator
Arm Description
use pipercill/tazobact to replace 3rd generation cephalosporin and collect rectal swab
Intervention Type
Drug
Intervention Name(s)
Tazocin (pipercillin/tazobactam)
Intervention Description
over 50% third generation cephalosporin should be replaced by Pip/Taz
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For China, medinfo@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study Evaluation Tazocin Intervention
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