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A Global Active Surveillance for Community Acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT00929721
Recruitment Status : Completed
First Posted : June 29, 2009
Last Update Posted : April 13, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5172 participants
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
Study Start Date : December 2009
Primary Completion Date : January 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  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 [ Time Frame: up to 120 days from enrollment ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: June 29, 2009    Key Record Dates
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