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A Global Active Surveillance for Community Acquired Pneumonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929721
First Posted: June 29, 2009
Last Update Posted: April 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention
Community Acquired Pneumonia Procedure: Blood draw Procedure: Chest X-ray Procedure: urine specimen Procedure: Nasopharyngeal swab Procedure: sputum

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Global Active Surveillance for Community-Acquired Pneumonia (CAP) in Adults 50 Years and Older

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence rates of CAP in adults 50 years and older [ Time Frame: up to 120 days from enrollment ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5172
Study Start Date: December 2009
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Subjects with Community-Acquired Pneumonia
Subjects with Community-Acquired Pneumonia
Procedure: Blood draw
culture for Streptococcus pneumoniae Frequency-1
Other Name: Blood stick
Procedure: Chest X-ray
image of the lungs to assess changes consistent with pneumonia Frequency-1
Other Name: Picture of lungs
Procedure: urine specimen
assay for the presence of Streptococcus pneumoniae Binax and UAD
Other Name: urine dipstick test
Procedure: Nasopharyngeal swab
culture for Streptococcus pneumoniae Frequency-1
Other Name: swab from inside the nose and throat
Procedure: sputum
culture for Streptococcus pneumoniae Frequency-1
Other Name: collection secretions produced during cough

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929721


Locations
Poland
Pfizer Investigational Site
Chrzanow, Poland, 32-500
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00929721     History of Changes
Other Study ID Numbers: 6115A1-4000
First Submitted: June 26, 2009
First Posted: June 29, 2009
Last Update Posted: April 13, 2012
Last Verified: April 2012

Keywords provided by Pfizer:
CAP

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections