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

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ClinicalTrials.gov Identifier: NCT01086397
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):

March 11, 2010
March 15, 2010
March 15, 2012
February 2010
September 2011   (Final data collection date for primary outcome measure)
Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae. [ Time Frame: 6-12 months ]
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 ]
Complete list of historical versions of study NCT01086397 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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)
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).
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
urine serum and potentially blood isolates
Non-Probability Sample
Adults 50 years and older presenting to Selected US Hospitals With Chest X-ray Confirmed Community-Acquired Pneumonia (CAP)
  • Pneumonia, Pneumococcal
  • Vaccines, Pneumococcal
Procedure: Urine sample collection
All subjects have non-invasive urine sample collection performed
1
Intervention: Procedure: Urine sample collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
782
October 2011
September 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01086397
6115A1-4007
B1851032
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012