Study Evaluation Tazocin Intervention

Bacterial Infections Clinical Trial

Official title:

Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) Producing Bacteria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488189
• Other study ID #: 0910X-102370
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2007
• Last updated: April 14, 2011
• Start date: May 2007
• Est. completion date: February 2008

Study information

• Verified date: June 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an antibiotic intervention study to determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients admitted or transferred to ICU/Pulmonary units

• Patients of either sex, 18 years of age or older

Exclusion Criteria:

• Patients who stay in units less than 48 hours will not be enrolled.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Drug:
• Tazocin (pipercillin/tazobactam)
over 50% third generation cephalosporin should be replaced by Pip/Taz

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. The acquisition rate of ESBL producing E. coli or K. Pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months of intervention phase)		9 months	No
Secondary	The infection rate due to ESBL producing E. coli or K. pnumoniae at the end of phase I (pre-intervention) and phase II (last 3 months of intervention phase)		9 months	No