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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01086397
First received: March 11, 2010
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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 Intervention
Pneumonia, Pneumococcal
Vaccines, Pneumococcal
Procedure: Urine sample collection

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae. [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with VT-type pneumonia by previous healthcare facility exposure status will be described by site. [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
  • Proportion of subjects with detection of S. pneumoniae by culture, BinaxNOW, and UAD assay will be summarized by method. [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
  • Serotype distribution of S. pneumoniae cases by site and across all sites. [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

urine serum and potentially blood isolates


Enrollment: 782
Study Start Date: February 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Procedure: Urine sample collection
All subjects have non-invasive urine sample collection performed

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086397

Locations
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
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01086397     History of Changes
Other Study ID Numbers: 6115A1-4007, B1851032
Study First Received: March 11, 2010
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pneumococcal pneumonia
community-acquired pneumonia

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Pneumococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial

ClinicalTrials.gov processed this record on August 20, 2014