Pneumonia, PneumococcalNCT01086397
Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia
An observational study of Pneumonia, Pneumococcal and Vaccines, Pneumococcal, run by Pfizer at 14 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pneumonia, Pneumococcal, Vaccines, Pneumococcal
- What is being tested?
- Urine sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 782 participants
- Where
- 14 sitesUnited States
- Study dates
- Feb 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 50 years and older presenting to Selected US Hospitals With Chest X-ray Confirmed Community-Acquired Pneumonia (CAP)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Summa Infectious Diseases
Akron, Ohio, 44304
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Detroit Receiving Hospital
Detroit, Michigan, 48201
Sinai Grace Hospital
Detroit, Michigan, 48235
Sharpe-Grossmont Hospital
La Mesa, California, 91942
eStudySite
Las Vegas, Nevada, 89109
University of South Alabama Division of Clinical Research
Mobile, Alabama, 36617
Sentara Norfolk General Hospital Cardiac Research 600 Gresh
Norfolk, Virginia, 23507
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, 01199
Tampa General Hospital
Tampa, Florida, 33606
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
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)
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).
- Conditions
- Pneumonia, Pneumococcal, Vaccines, Pneumococcal
- Being tested
- Urine sample collection
- Keywords
- pneumococcal pneumonia, community-acquired pneumonia
- Medical subject headings
- Pneumonia, Pneumococcal, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine sample collectionProcedure or surgery
All subjects have non-invasive urine sample collection performed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Procedure: Urine sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae.
Measured: 6-12 months
Secondary outcomes (3)
Proportion of subjects with VT-type pneumonia by previous healthcare facility exposure status will be described by site.
Measured: 6-12 months
Proportion of subjects with detection of S. pneumoniae by culture, BinaxNOW, and UAD assay will be summarized by method.
Measured: 6-12 months
Serotype distribution of S. pneumoniae cases by site and across all sites.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, PneumococcalStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086397
- Sponsor's protocol ID
- 6115A1-4007
- Other IDs
- B1851032
- Status last verified
- Mar 2012
- First submitted
- 11 Mar 2010
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01086397
- Acronym / sponsor ID
- 6115A1-4007
- Conditions
- Pneumonia, Pneumococcal, Vaccines, Pneumococcal
- Keywords
- pneumococcal pneumonia, community-acquired pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 782 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Urine sample collection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 50 years and older presenting to Selected US Hospitals With Chest X-ray Confirmed Community-Acquired Pneumonia (CAP)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine sample collectionAll subjects have non-invasive urine sample collection performed | Procedure or surgery | 1 |
Primary outcome
Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae.
Time frame: 6-12 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Pneumococcal and Vaccines, Pneumococcal, run by Pfizer at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae. (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2012.