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Tazocin Intervention Study

Primary Purpose

Bacterial Infections

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Tazocin (Piperacillin/Tazobactem)

About this trial

This is an interventional prevention trial for Bacterial Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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 Outcome Measures

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)

Full Information

NCT ID

NCT00478855

First Posted

May 24, 2007

Last Updated

December 7, 2007

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00478855

Brief Title

Tazocin Intervention Study

Official Title

Association of Antibiotic Utilization Measures and Control of ESBLs Producing Bacteria

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

500 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tazocin (Piperacillin/Tazobactem)

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

Facility Information:

City

Peking

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

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Tazocin Intervention Study

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