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Study Evaluating Antibiotic Utilization Measures and Control of Extended-Spectrum-Lactamases (ESBLs)

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ClinicalTrials.gov Identifier: NCT00254696
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : April 15, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
  • To determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection.
  • To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre and post intervention in the selected medical centers.

Condition or disease Intervention/treatment Phase
Bacterial Infection Drug: Extended-Spectrum-Lactamases (ESBLs) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 710 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Association of Antibiotic Utilization Measures and Control of Extended-spectrum-lactamases (ESBLs)
Study Start Date : June 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months)

Secondary Outcome Measures :
  1. Infection rate of ESBL producing E. coli or K. Pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months)


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:

  • Patients admitted or transferred to the ICU/pulmonary/hematology units.
  • Patients of either sex, 18 years of age or older

Exclusion Criteria:

  • Pregnant and nursing women. Female of childbearing potential without using any birth control methods. Female of childbearing potential using oral contraceptives during study period. (Note: penicillin and beta-lactamase inhibitors may prevent oral contraceptives from working properly, increasing the chance of pregnancy).
  • Patients who have the contraindications of using Tazocin (pipercillin/tazobactam)

Other exclusions apply.


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): NCT00254696


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 China medinfo@wyeth.com

ClinicalTrials.gov Identifier: NCT00254696     History of Changes
Other Study ID Numbers: 0910X-101462
First Posted: November 16, 2005    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
bacterial infection

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