Study of Antibiotic Utilization Measures and Control of ESBLs in China

Phase 4

Completed

• Conditions: ICU Patient

• Registration Number: NCT00488813
• Lead Sponsor: 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

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 Timeline

• Study Start: 2004-07
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2007-06-18
• Study First Submitted QC: 2007-06-19
• Study First Posted: 2007-06-20
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-04
• Last Update Posted: 2009-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).