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

Last updated on November 13, 2019

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Study Location
University of South Alabama Division of Clinical Research
Mobile, Alabama, 36617 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Pneumonia, Pneumococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01086397
Pfizer
Completed
Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia

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Descriptive Information
Brief TitleEpidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia
Official TitleDistribution Of PCV13 Serotype Streptococcus Pneumoniae In Adults 50 Years And Older Presenting To Select US Hospitals With Radiographically-Confirmed Community-Acquired Pneumonia (CAP)
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples Without DNA
Description:
urine serum and potentially blood isolates
Sampling MethodNon-Probability Sample
Study PopulationAdults 50 years and older presenting to Selected US Hospitals With Chest X-ray Confirmed Community-Acquired Pneumonia (CAP)
Condition
  • Pneumonia, Pneumococcal
  • Vaccines, Pneumococcal
InterventionProcedure: Urine sample collection
All subjects have non-invasive urine sample collection performed
Study Groups/Cohorts1
Intervention: Procedure: Urine sample collection
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: March 14, 2012)
782
Original Estimated Enrollment
 (submitted: March 12, 2010)
1302
Actual Study Completion DateOctober 2011
Actual Primary Completion DateSeptember 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
Ages50 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01086397
Other Study ID Numbers6115A1-4007
B1851032
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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