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

Pfizer782 enrolled

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).

Study Type

OBSERVATIONAL

Enrollment

782

Conditions

Pneumonia, Pneumococcal Vaccines, Pneumococcal

Interventions

Urine sample collectionPROCEDURE

All subjects have non-invasive urine sample collection performed

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (14)

University of South Alabama Division of Clinical Research

Mobile, Alabama, United States

Sharpe-Grossmont Hospital

La Mesa, California, United States

Outcomes

Primary Outcomes

Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae.

Time frame: 6-12 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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