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

March 14, 2012 updated by: Pfizer

Distribution Of PCV13 Serotype Streptococcus Pneumoniae In Adults 50 Years And Older Presenting To Select US Hospitals With Radiographically-Confirmed Community-Acquired Pneumonia (CAP)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

782

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • University of South Alabama Division of Clinical Research
    • California
      • La Mesa, California, United States, 91942
        • Sharpe-Grossmont Hospital
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Infectious Diseases Clinical Research
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving Hospital
      • Detroit, Michigan, United States, 48235
        • Sinai Grace Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • eStudySite
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Infectious Diseases
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital Cardiac Research 600 Gresh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults 50 years and older presenting to Selected US Hospitals With Chest X-ray Confirmed Community-Acquired Pneumonia (CAP)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Procedure: Urine sample collection
All subjects have non-invasive urine sample collection performed

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with VT-type pneumonia by previous healthcare facility exposure status will be described by site.
Time Frame: 6-12 months
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
6-12 months
Serotype distribution of S. pneumoniae cases by site and across all sites.
Time Frame: 6-12 months
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Estimate)

March 15, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6115A1-4007
  • B1851032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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