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
  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:


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
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, see Learn About Clinical Studies.

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:
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 August 20, 2014