Tazocin Intervention Study

Bacterial Infections Clinical Trial

Official title:

Association of Antibiotic Utilization Measures and Control of ESBLs Producing Bacteria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478855
• Other study ID #: 0910X-102105
• Status: Completed
• Phase: Phase 4
• First received: May 24, 2007
• Last updated: December 7, 2007
• Start date: September 2006
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• 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

1. To determine the value of using piperacillin/tazobactam in reducing the cases of extended spectrum beta lactamases (ESBL) producing E. coli or K. pneumoniae colonization and infection.

2. To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre-and post-intervention in the selected medical centers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients admitted or transferred to the ICU/pulmonary/Infection units

• Patients of either sex, 18 years of age or older Patients who stay in units less than 48 hours will not be enrolled.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Drug:
• Tazocin (Piperacillin/Tazobactem)

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	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; post-intervention)
Secondary	The infection rate due to ESBL producing E. coli or K. pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months; post-intervention)