Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia

Overview

The main purpose of this study is to use an investigational urine assay to estimate the proportion of pneumonia in adults 50 years or older in different areas throughout the US that is caused by certain types of the bacteria Streptococcus pneumoniae (also called pneumococcus).

Full Title of Study: “Distribution Of PCV13 Serotype Streptococcus Pneumoniae In Adults 50 Years And Older Presenting To Select US Hospitals With Radiographically-Confirmed Community-Acquired Pneumonia (CAP)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2011

Interventions

  • Procedure: Urine sample collection
    • All subjects have non-invasive urine sample collection performed

Arms, Groups and Cohorts

  • 1

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae.
    • Time Frame: 6-12 months

Secondary Measures

  • Proportion of subjects with VT-type pneumonia by previous healthcare facility exposure status will be described by site.
    • Time Frame: 6-12 months
  • Proportion of subjects with detection of S. pneumoniae by culture, BinaxNOW, and UAD assay will be summarized by method.
    • Time Frame: 6-12 months
  • Serotype distribution of S. pneumoniae cases by site and across all sites.
    • Time Frame: 6-12 months

Participating in This Clinical Trial

Inclusion Criteria

  • Age 50 years and older. – Presents to a study site with clinically suspected pneumonia. – Has a radiographic finding that is consistent with pneumonia. – Able and willing to provide urine. Exclusion Criteria:

  • Transfer to a study hospital after already being hospitalized for 48 hours or more at any other inpatient facility (such as community hospital). – Hospital-acquired pneumonia (ie, pneumonia developing 48 hours after hospital admission). – Previous enrollment in this study within the past 30 days.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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