A Global Active Surveillance for Community Acquired Pneum... | NCT00929721

Studies
A Global Active Surveillance for Community Acquired Pneumonia

NCT00929721

Sponsor

Pfizer

Status

Completed

Last Update Posted

Apr 13, 2012Estimated

Enrollment

5,172Actual

Phase

Not Applicable

Conditions

Community Acquired Pneumonia

Interventions

Blood draw
Chest X-ray
urine specimen
Nasopharyngeal swab
sputum

Countries

Poland

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

Apr 2012

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 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jun 26, 2009

First Submission Date that Met QC Criteria

Jun 26, 2009

First Posted Date

Jun 29, 2009Estimated

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

Apr 12, 2012

Last Update Posted Date

Apr 13, 2012Estimated

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

This study is an observational surveillance study to identify adults 50 years and older who present to a study healthcare facility with signs and symptoms of Community-Acquired Pneumonia.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5,172Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects with Community-Acquired Pneumonia	Other	Subjects with Community-Acquired Pneumonia	Procedure: Blood draw Procedure: Chest X-ray Procedure: urine specimen Procedure: Nasopharyngeal swab Procedure: sputum

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw	Procedure	culture for Streptococcus pneumoniae Frequency-1	Subjects with Community-Acquired Pneumonia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence rates of CAP in adults 50 years and older		up to 120 days from enrollment

Secondary Outcomes

Measure	Description	Time Frame
Frequency of bacterial agents associated with CAP, Case fatality and incidence rates of CAP number and characteristics of subjects from outpatient clinics, emergency rooms, and hospital in-patient departments		up to 120 days from enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult subjects 50 years of age or older
Subject must reside in the surveillance area
Subjects who present to a study healthcare facility where the treating physician clinically suspects CAP

Exclusion Criteria:

Any subject who is transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility (such as a community hospital).
Hospital Acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 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
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Chrzanów		32-500	Poland

References Module

Citations

Not provided

ID	Term
D017714	Community-Acquired Infections
D007239	Infections
D011014	Pneumonia
D012141	Respiratory Tract Infections

ID	Term
D001800	Blood Specimen Collection
D014965	X-Rays
D059349	Urine Specimen Collection

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis