Clinical Trial: Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Distribution Of PCV13 Serotype Streptococcus Pneumoniae In Adults 50 Years And Older Presenting To Select US Hospitals With Radiographically-Confirmed Community-Acquired Pneumonia (CAP)
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 Summary:
Sponsor: Pfizer
Current Primary Outcome: Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae. [ Time Frame: 6-12 months ]
Original Primary Outcome: Using an investigational assay, to estimate the proportion of PCV13 serotype S pneumoniae among adults, 50 years of age and older presenting with chest x-ray confirmed CAP to selected US hospitals. [ Time Frame: 18 months ]
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- To describe the distribution of selected viral nasal pathogens. [ Time Frame: 18 months ]
- To describe the differences in detection of S pneumoniae by blood culture, BinaxNOW®, and UAD assay. [ Time Frame: 18 months ]
Information By: Pfizer
Dates:
Date Received: March 11, 2010
Date Started: February 2010
Date Completion:
Last Updated: March 14, 2012
Last Verified: March 2012
