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

Pneumonia, Pneumococcal Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086397
• Other study ID #: 6115A1-4007
• Secondary ID: B1851032
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: March 14, 2012
• Start date: February 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 782
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Pneumococcal
• Vaccines, Pneumococcal

Intervention

Procedure:
• Urine sample collection
All subjects have non-invasive urine sample collection performed

Locations

Country	Name	City	State
United States	Summa Infectious Diseases	Akron	Ohio
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Detroit Receiving Hospital	Detroit	Michigan
United States	Sinai Grace Hospital	Detroit	Michigan
United States	Sharpe-Grossmont Hospital	La Mesa	California
United States	eStudySite	Las Vegas	Nevada
United States	University of South Alabama Division of Clinical Research	Mobile	Alabama
United States	Sentara Norfolk General Hospital Cardiac Research 600 Gresh	Norfolk	Virginia
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Baystate Infectious Diseases Clinical Research	Springfield	Massachusetts
United States	Tampa General Hospital	Tampa	Florida
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae.		6-12 months	No
Secondary	Proportion of subjects with VT-type pneumonia by previous healthcare facility exposure status will be described by site.		6-12 months	No
Secondary	Proportion of subjects with detection of S. pneumoniae by culture, BinaxNOW, and UAD assay will be summarized by method.		6-12 months	No
Secondary	Serotype distribution of S. pneumoniae cases by site and across all sites.		6-12 months	No

External Links

•   To obtain contact information for a study center near you, click here.