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)
2 other identifiers
observational
782
1 country
14
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2010
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 11, 2010
CompletedFirst Posted
Study publicly available on registry
March 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedMarch 15, 2012
March 1, 2012
1.6 years
March 11, 2010
March 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae.
6-12 months
Secondary Outcomes (3)
Proportion of subjects with VT-type pneumonia by previous healthcare facility exposure status will be described by site.
6-12 months
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
Study Arms (1)
1
Interventions
Eligibility Criteria
Adults 50 years and older presenting to Selected US Hospitals With Chest X-ray Confirmed Community-Acquired Pneumonia (CAP)
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (14)
University of South Alabama Division of Clinical Research
Mobile, Alabama, 36617, United States
Sharpe-Grossmont Hospital
La Mesa, California, 91942, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, 01199, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Sinai Grace Hospital
Detroit, Michigan, 48235, United States
eStudySite
Las Vegas, Nevada, 89109, United States
Summa Infectious Diseases
Akron, Ohio, 44304, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Sentara Norfolk General Hospital Cardiac Research 600 Gresh
Norfolk, Virginia, 23507, United States
Related Links
Biospecimen
urine serum and potentially blood isolates
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2010
First Posted
March 15, 2010
Study Start
February 1, 2010
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
March 15, 2012
Record last verified: 2012-03