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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01086397

Enrollment

782

Registered

2010-03-15

Start date

2010-02-28

Completion date

2011-10-31

Last updated

2012-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Pneumococcal, Vaccines, Pneumococcal

Keywords

pneumococcal pneumonia, community-acquired pneumonia

Brief summary

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).

Interventions

PROCEDUREUrine sample collection

All subjects have non-invasive urine sample collection performed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026