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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01086397
First received: March 11, 2010
Last updated: March 14, 2012
Last verified: March 2012
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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
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 May 16, 2013