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A Global Active Surveillance for Community Acquired Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00929721
First received: June 26, 2009
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  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: Open Label
Official Title: Global Active Surveillance for Community-Acquired Pneumonia (CAP) in Adults 50 Years and Older

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00929721     History of Changes
Other Study ID Numbers: 6115A1-4000
Study First Received: June 26, 2009
Last Updated: April 12, 2012
Health Authority: Poland: Ministry of Health

Keywords provided by Pfizer:
CAP

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

ClinicalTrials.gov processed this record on May 19, 2013