Clinical trial NCT01086397: Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Pneumococcal
Vaccines, Pneumococcal
Keywords: pneumococcal pneumonia
community-acquired pneumonia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 782
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 50 years and older presenting to Selected US Hospitals With Chest X-ray 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae.
timeFrame: 6-12 months
Secondary outcomes:
measure: Proportion of subjects with VT-type pneumonia by previous healthcare facility exposure status will be described by site.
timeFrame: 6-12 months
measure: Proportion of subjects with detection of S. pneumoniae by culture, BinaxNOW, and UAD assay will be summarized by method.
timeFrame: 6-12 months
measure: Serotype distribution of S. pneumoniae cases by site and across all sites.
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Division of Clinical Research
state: Alabama
city: La Mesa
country: United States
facility: Sharpe-Grossmont Hospital
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Springfield
country: United States
facility: Baystate Infectious Diseases Clinical Research
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Detroit
country: United States
facility: Sinai Grace Hospital
state: Michigan
city: Las Vegas
country: United States
facility: eStudySite
state: Nevada
city: Akron
country: United States
facility: Summa Infectious Diseases
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital Cardiac Research 600 Gresh
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: