Study Evaluation Tazocin Intervention

NCT00488189

Last updated date
Study Location
Beijing, Beijing, 100037, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- All patients admitted or transferred to ICU/Pulmonary units

- Patients of either sex, 18 years of age or older

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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
  • No Intervention: 1
    baseline, collecting rectal swab samples
  • Active Comparator: 2
    use pipercill/tazobact to replace 3rd generation cephalosporin and collect rectal swab
    Intervention: Drug: Tazocin (pipercillin/tazobactam)
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
 (submitted: April 14, 2011)
134
Original Enrollment  ICMJE
 (submitted: June 18, 2007)
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:

  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor China, [email protected]
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