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Completed

NCT Number: NCT01086397

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

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).

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Key information

Conditions

Pneumonia, Pneumococcal Bacterial Infections Bacterial Infections and Mycoses Community-Acquired Infections Community-Acquired Pneumonia Gram-Positive Bacterial Infections Infections Lung Diseases Pneumococcal Infections Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections Vaccines, Pneumococcal

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Alabama Division of Clinical Research, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urine sample collection

Procedure

All subjects have non-invasive urine sample collection performed

Primary outcomes

  1. Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae.

    Time frame: 6-12 months

Secondary outcomes

  1. Proportion of subjects with VT-type pneumonia by previous healthcare facility exposure status will be described by site.

    Time frame: 6-12 months

  2. Proportion of subjects with detection of S. pneumoniae by culture, BinaxNOW, and UAD assay will be summarized by method.

    Time frame: 6-12 months

  3. Serotype distribution of S. pneumoniae cases by site and across all sites.

    Time frame: 6-12 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 15, 2010
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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