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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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).

Condition or disease Intervention/treatment
Pneumonia, Pneumococcal Vaccines, Pneumococcal Procedure: Urine sample collection

Study Design
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Study Type : Observational
Actual Enrollment : 782 participants
Time Perspective: Prospective
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 Start Date : February 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
1 Procedure: Urine sample collection
All subjects have non-invasive urine sample collection performed


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae. [ Time Frame: 6-12 months ]

Secondary Outcome Measures :
  1. Proportion of subjects with VT-type pneumonia by previous healthcare facility exposure status will be described by site. [ Time Frame: 6-12 months ]
  2. Proportion of subjects with detection of S. pneumoniae by culture, BinaxNOW, and UAD assay will be summarized by method. [ Time Frame: 6-12 months ]
  3. Serotype distribution of S. pneumoniae cases by site and across all sites. [ Time Frame: 6-12 months ]

Biospecimen Retention:   Samples Without DNA
urine serum and potentially blood isolates

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086397


Locations
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United States, Alabama
University of South Alabama Division of Clinical Research
Mobile, Alabama, United States, 36617
United States, California
Sharpe-Grossmont Hospital
La Mesa, California, United States, 91942
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Massachusetts
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, United States, 01199
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Sinai Grace Hospital
Detroit, Michigan, United States, 48235
United States, Nevada
eStudySite
Las Vegas, Nevada, United States, 89109
United States, Ohio
Summa Infectious Diseases
Akron, Ohio, United States, 44304
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Sentara Norfolk General Hospital Cardiac Research 600 Gresh
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01086397    
Other Study ID Numbers: 6115A1-4007
B1851032
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012
Keywords provided by Pfizer:
pneumococcal pneumonia
community-acquired pneumonia
Additional relevant MeSH terms:
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Pneumonia, Pneumococcal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial