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Trial record 1 of 1 for:    NCT01086397
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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):
Pfizer

Tracking Information
First Submitted Date March 11, 2010
First Posted Date March 15, 2010
Last Update Posted Date March 15, 2012
Study Start Date February 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2010)
Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae. [ Time Frame: 6-12 months ]
Original Primary Outcome Measures
 (submitted: March 12, 2010)
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 ]
Change History Complete list of historical versions of study NCT01086397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 24, 2010)
  • 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 Measures
 (submitted: March 12, 2010)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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 Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
urine serum and potentially blood isolates
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)
Condition
  • Pneumonia, Pneumococcal
  • Vaccines, Pneumococcal
Intervention Procedure: Urine sample collection
All subjects have non-invasive urine sample collection performed
Study Groups/Cohorts 1
Intervention: Procedure: Urine sample collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 14, 2012)
782
Original Estimated Enrollment
 (submitted: March 12, 2010)
1302
Actual Study Completion Date October 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01086397
Other Study ID Numbers 6115A1-4007
B1851032
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2012