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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01086397

Collaborator

(none)

782

Enrollment

Locations

19.9

Duration (Months)

55.9

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

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 :

Feb 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
1	Procedure: Urine sample collection All subjects have non-invasive urine sample collection performed

Outcome Measures

Primary Outcome Measures

Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae. [6-12 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama Division of Clinical Research	Mobile	Alabama	United States	36617
2	Sharpe-Grossmont Hospital	La Mesa	California	United States	91942
3	Tampa General Hospital	Tampa	Florida	United States	33606
4	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
5	Baystate Infectious Diseases Clinical Research	Springfield	Massachusetts	United States	01199
6	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01605
7	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
8	Detroit Receiving Hospital	Detroit	Michigan	United States	48201
9	Sinai Grace Hospital	Detroit	Michigan	United States	48235
10	eStudySite	Las Vegas	Nevada	United States	89109
11	Summa Infectious Diseases	Akron	Ohio	United States	44304
12	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103
13	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229
14	Sentara Norfolk General Hospital Cardiac Research 600 Gresh	Norfolk	Virginia	United States	23507