A Post-Intervention Surveillance Study Regarding the Acqu... | NCT00724919

Studies
A Post-Intervention Surveillance Study Regarding the Acquisition Rate of ESBL-KP, Ecoli

NCT00724919

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Aug 11, 2008Estimated

Enrollment

256Actual

Phase

Not provided

Conditions

Infection

Interventions

Not provided

Countries

Taiwan

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

Aug 2008

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

Dec 2003

Primary Completion Date

Apr 2004Actual

Completion Date

Apr 2004Actual

First Submitted Date

Jul 23, 2008

First Submission Date that Met QC Criteria

Jul 25, 2008

First Posted Date

Jul 30, 2008Estimated

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

Aug 7, 2008

Last Update Posted Date

Aug 11, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This is post-interventional study to follow the acquisition rate of ESBP producing E. coli or K. pneumoniae at the sites involved in a previous interventional study.

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

256Actual

Label	Type	Description	Intervention Names
1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of surveillance phase		48hours

Secondary Outcomes

Measure	Description	Time Frame
The infection rate due to ESBL producing E. coli, or due to K. pneumoniae at the end of surveillance phase		48hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion

All patients admitted or transferred to ICU/burn unit.
Patients of either sex, 18 years of age or older. Exclusion

Patients were excluded if they had underlying conditions or diseases that were ultimately fatal within 48 hours

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

patients admitted to ICU/burn unit

Sampling Method

Non-Probability Sample

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
		Miaoli County		351	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided