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

Phase 4

Completed

• Conditions: Bacterial Infection

• Registration Number: NCT00254696
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-16
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 710

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Infection rate of ESBL producing E. coli or K. Pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months)