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Study of Antibiotic Utilization Measures and Control of ESBLs in China

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ClinicalTrials.gov Identifier: NCT00488813
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : September 9, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
A single-center, prospective, comparative, antibiotic intervention study for patients admitted to MICU1 and MICU2

Condition or disease Intervention/treatment Phase
ICU Patient Drug: Third generation cephalosporins Phase 4

Detailed Description:
  1. To determine the value of using β-lactamases inhibitors in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection after 12 months.
  2. To compare the acquisition rates of ESBL producing E. coli or K. pneumoniae at MICU1 and MICU2 after 12 months

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Association of Antibiotic Utilization Measures and Control of Extended-spectrum β-lactamases (ESBLs) in MICU1 and MICU2 at Buddhist Tzu Chi General Hospital.
Study Start Date : July 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources




Primary Outcome Measures :
  1. For both MICU1 and MICU2 (acquisition), all culture results will be collected and recorded, then analyzed to determine the ESBL acquisition rate and bacterial isolates (E. coli or K. pneumoniae).


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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 the ICU/burn units.
  • Patients of either sex, 18 years of age or older.

Exclusion Criteria:

  • Patient with hypersensitivity to penicillins, cephalosporins, and beta-lactamase inhibitors.

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): NCT00488813


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Taiwan, medinfo@wyeth.com

ClinicalTrials.gov Identifier: NCT00488813     History of Changes
Other Study ID Numbers: 101441
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: September 9, 2009
Last Verified: September 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Tzh-Chi ESBL study

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cephalosporins
Anti-Infective Agents