A Global Active Surveillance for Community Acquired Pneumonia

Community Acquired Pneumonia Clinical Trial

Official title:

Global Active Surveillance for Community-Acquired Pneumonia (CAP) in Adults 50 Years and Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929721
• Other study ID #: 6115A1-4000
• Status: Completed
• Phase: N/A
• First received: June 26, 2009
• Last updated: April 12, 2012
• Start date: December 2009
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5172
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Intervention

Procedure:
• Blood draw
culture for Streptococcus pneumoniae Frequency-1
• Chest X-ray
image of the lungs to assess changes consistent with pneumonia Frequency-1
• urine specimen
assay for the presence of Streptococcus pneumoniae Binax and UAD
• Nasopharyngeal swab
culture for Streptococcus pneumoniae Frequency-1
• sputum
culture for Streptococcus pneumoniae Frequency-1

Locations

Country	Name	City	State
Poland	Pfizer Investigational Site	Chrzanow

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rates of CAP in adults 50 years and older		up to 120 days from enrollment	No
Secondary	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	No

External Links

•   To obtain contact information for a study center near you, click here.