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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00254696
First Posted: November 16, 2005
Last Update Posted: April 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
  • 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 Intervention Phase
Bacterial Infection Drug: Extended-Spectrum-Lactamases (ESBLs) Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Enrollment: 710
Study Start Date: June 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00254696     History of Changes
Other Study ID Numbers: 0910X-101462
First Submitted: November 14, 2005
First Posted: November 16, 2005
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