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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00478855
Other study ID # 0910X-102105
Secondary ID
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
Est. primary completion date
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


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)
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