A Global Active Surveillance for Community Acquired Pneumonia

April 12, 2012 updated by: Pfizer

Global Active Surveillance for Community-Acquired Pneumonia (CAP) in Adults 50 Years and Older

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Chrzanow, Poland, 32-500
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Subjects with Community-Acquired Pneumonia
Procedure: Blood draw
culture for Streptococcus pneumoniae Frequency-1
Other Names:
  • Blood stick
Procedure: Chest X-ray
image of the lungs to assess changes consistent with pneumonia Frequency-1
Other Names:
  • Picture of lungs
Procedure: urine specimen
assay for the presence of Streptococcus pneumoniae Binax and UAD
Other Names:
  • urine dipstick test
Procedure: Nasopharyngeal swab
culture for Streptococcus pneumoniae Frequency-1
Other Names:
  • swab from inside the nose and throat
Procedure: sputum
culture for Streptococcus pneumoniae Frequency-1
Other Names:
  • collection secretions produced during cough

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: up to 120 days from enrollment
up to 120 days from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

June 26, 2009

First Submitted That Met QC Criteria

June 26, 2009

First Posted (Estimate)

June 29, 2009

Study Record Updates

Last Update Posted (Estimate)

April 13, 2012

Last Update Submitted That Met QC Criteria

April 12, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6115A1-4000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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