Tazocin Intervention Study | NCT00478855

Studies
Tazocin Intervention Study

NCT00478855

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Dec 10, 2007Estimated

Enrollment

500

Phase

Phase 4

Conditions

Bacterial Infections

Interventions

Tazocin (Piperacillin/Tazobactem)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

May 24, 2007

First Submission Date that Met QC Criteria

May 24, 2007

First Posted Date

May 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2007

Last Update Posted Date

Dec 10, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500

Name	Type	Description	Arm Group Labels	Other Names
Tazocin (Piperacillin/Tazobactem)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Beijing		100730	China

Condition Browse Module

MeSH Terms

ID	Term
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077725	Piperacillin, Tazobactam Drug Combination
D010878	Piperacillin

Ancestor Terms

ID	Term
D000078142	Tazobactam
D010397	Penicillanic Acid
D010406	Penicillins
D047090	beta-Lactams

Browse Leaves

Not provided

Browse Branches

Not provided