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

• ClinicalTrials.gov Identifier: NCT01086397
• Recruitment Status: Completed
• First Posted: March 15, 2010
• Last Update Posted: March 15, 2012
• Sponsor: Pfizer
• 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 ]

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

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

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