A Global Active Surveillance for Community Acquired Pneumonia

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NCT00929721

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Study Location
Pfizer Investigational Site
Chrzanow, , 32-500, Poland
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community Acquired Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Community Acquired PneumoniaA Global Active Surveillance for Community Acquired Pneumonia NCT00929721
  1. Chrzanow,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Global Active Surveillance for Community Acquired Pneumonia
Official Title  ICMJE Global Active Surveillance for Community-Acquired Pneumonia (CAP) in Adults 50 Years and Older
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Community Acquired Pneumonia
Intervention  ICMJE
  • 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
Study Arms  ICMJE Subjects with Community-Acquired Pneumonia
Subjects with Community-Acquired Pneumonia
Interventions:
  • Procedure: Blood draw
  • Procedure: Chest X-ray
  • Procedure: urine specimen
  • Procedure: Nasopharyngeal swab
  • Procedure: sputum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2012)		5172
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2009)		30000
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries Korea, Republic of
 
Administrative Information
NCT Number  ICMJE NCT00929721
Other Study ID Numbers  ICMJE 6115A1-4000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP