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ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Bacterial Infections
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- All patients admitted or transferred to ICU/Pulmonary units
- Patients of either sex, 18 years of age or older
Exclusion Criteria
Show details
- Patients who stay in units less than 48 hours will not be enrolled.
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Advanced Information
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | Study Evaluation Tazocin Intervention | ||||||
Official Title ICMJE | Association of Antibiotic Utilization Measures and Control of Extended-Spectrum ?-Lactamases (ESBLs) Producing Bacteria | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Health Services Research | ||||||
Condition ICMJE | Bacterial Infections | ||||||
Intervention ICMJE | Drug: Tazocin (pipercillin/tazobactam)
over 50% third generation cephalosporin should be replaced by Pip/Taz | ||||||
Study Arms ICMJE |
| ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 134 | ||||||
Original Enrollment ICMJE | 500 | ||||||
Actual Study Completion Date ICMJE | February 2008 | ||||||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Patients who stay in units less than 48 hours will not be enrolled. | ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00488189 | ||||||
Other Study ID Numbers ICMJE | 0910X-102370 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Director, Clinical Trial Disclosure Group, Wyeth | ||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Verification Date | June 2010 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |