Study of Antibiotic Utilization Measures and Control of ESBLs in China

NCT ID: NCT00488813

Last Updated: 2009-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2005-06-30

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

Conditions

ICU Patient

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Third generation cephalosporins

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Taiwan, medinfo@wyeth.com

Other Identifiers

101441

Identifier Type: -

Identifier Source: org_study_id