NCT00929721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

2.1 years

First QC Date

June 26, 2009

Last Update Submit

April 12, 2012

Conditions

Keywords

CAP

Outcome Measures

Primary Outcomes (1)

  • Incidence rates of CAP in adults 50 years and older

    up to 120 days from enrollment

Secondary Outcomes (1)

  • 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

Study Arms (1)

Subjects with Community-Acquired Pneumonia

OTHER

Subjects with Community-Acquired Pneumonia

Procedure: Blood drawProcedure: Chest X-rayProcedure: urine specimenProcedure: Nasopharyngeal swabProcedure: sputum

Interventions

Blood drawPROCEDURE

culture for Streptococcus pneumoniae Frequency-1

Also known as: Blood stick
Subjects with Community-Acquired Pneumonia
Chest X-rayPROCEDURE

image of the lungs to assess changes consistent with pneumonia Frequency-1

Also known as: Picture of lungs
Subjects with Community-Acquired Pneumonia

assay for the presence of Streptococcus pneumoniae Binax and UAD

Also known as: urine dipstick test
Subjects with Community-Acquired Pneumonia

culture for Streptococcus pneumoniae Frequency-1

Also known as: swab from inside the nose and throat
Subjects with Community-Acquired Pneumonia
sputumPROCEDURE

culture for Streptococcus pneumoniae Frequency-1

Also known as: collection secretions produced during cough
Subjects with Community-Acquired Pneumonia

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Chrzanów, 32-500, Poland

Location

Related Links

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Blood Specimen CollectionX-RaysUrine Specimen Collection

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2009

First Posted

June 29, 2009

Study Start

December 1, 2009

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations