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

Completed

• Conditions: Vaccines, Pneumococcal; Pneumonia, Pneumococcal
• Interventions: Procedure: Urine sample collection

• Registration Number: NCT01086397
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 782

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Urine sample collection	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (13)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

University of Massachusetts Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States

eStudySite; 🇺🇸 Las Vegas, Nevada, United States

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

University of South Alabama Division of Clinical Research; 🇺🇸 Mobile, Alabama, United States

Sinai Grace Hospital; 🇺🇸 Detroit, Michigan, United States

Summa Infectious Diseases; 🇺🇸 Akron, Ohio, United States

Baystate Infectious Diseases Clinical Research; 🇺🇸 Springfield, Massachusetts, United States

Detroit Receiving Hospital; 🇺🇸 Detroit, Michigan, United States

Sharpe-Grossmont Hospital; 🇺🇸 La Mesa, California, United States

Sentara Norfolk General Hospital Cardiac Research 600 Gresh; 🇺🇸 Norfolk, Virginia, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States