Study Evaluating Piperacillin-Tazobactam on Certain Bacte... | NCT00167999

Studies
Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units

NCT00167999

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Mar 15, 2007Estimated

Enrollment

200

Phase

Not provided

Conditions

Gram-Positive Bacterial Infections
Escherichia Coli Infections
Klebsiella Infections

Interventions

piperacillin-tazobactam

Countries

South Korea

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

Mar 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

Feb 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 11, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 14, 2005Estimated

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

Mar 14, 2007

Last Update Posted Date

Mar 15, 2007Estimated

Description Module

Brief Summary

To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in hematology and oncology units

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
piperacillin-tazobactam	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible patients of either sex, 15 years of age or older
Patients who are admitted to the department of hematology and oncology
Provide written informed consent

Exclusion Criteria:

Patients who have hypersensitivity to β-lactam antibiotics
Female who are pregnant or breast-feeding
Any underlying conditions or non-infectious diseases that will be ultimately fatal within 30 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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
		Seoul		133-792	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D004927	Escherichia coli Infections
D007710	Klebsiella Infections
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D004756	Enterobacteriaceae Infections
D016905	Gram-Negative Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077725	Piperacillin, Tazobactam Drug Combination

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided