Clincosm LogoSign in Get a demo

A Global Active Surveillance for Community Acquired Pneumonia

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00929721
Collaborator
(none)
5,172
Enrollment
1
Location
1
Arm
26
Duration (Months)
198.8
Patients Per Site Per Month

Study Details

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 Phase
  • Procedure: Blood draw
  • Procedure: Chest X-ray
  • Procedure: urine specimen
  • Procedure: Nasopharyngeal swab
  • Procedure: sputum
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
5172 participants
Allocation:
N/A
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 :
Dec 1, 2009
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Other: Subjects with Community-Acquired Pneumonia

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence rates of CAP in adults 50 years and older [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 [up to 120 days from enrollment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Chrzanow Poland 32-500

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00929721
    Other Study ID Numbers:
    • 6115A1-4000
    First Posted:
    Jun 29, 2009
    Last Update Posted:
    Apr 13, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Pfizer
    CAP
    Additional relevant MeSH terms:
    Pneumonia

    Study Results

    No Results Posted as of Apr 13, 2012