Study of Antibiotic Utilization Measures and Control of ESBLs in China

ICU Patient Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488813
• Other study ID #: 101441
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2007
• Last updated: September 4, 2009
• Start date: July 2004
• Est. completion date: June 2005

Study information

• Verified date: September 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ICU Patient

Intervention

Drug:
• Third generation cephalosporins

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).