Official Title: “Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) in MICU1 and MICU2 at Buddhist Tzu Chi General Hospital.”

A single-center, prospective, comparative, antibiotic intervention study for patients admitted to MICU1 and MICU2

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Intervention(s) in this Clinical Trial

• Drug: Third generation cephalosporins

Primary Measures

• 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).

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00488813

Study ID Number: 101441

ClinicalTrials.gov Identifier: NCT00488813

Health Authority: Taiwan: Department of Health