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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00254696
First received: November 14, 2005
Last updated: April 13, 2011
Last verified: April 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00254696     History of Changes
Other Study ID Numbers: 0910X-101462
Study First Received: November 14, 2005
Last Updated: April 13, 2011
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 16, 2014