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NCT Number: NCT00637351

A Study in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays

GSK Biologicals is working on the development of a vaccine to protect elderly people from bacterial pneumonia. Diagnostic of bacterial pneumonia is difficult, and for the future studies in that project, it would be useful to have some easy non invasive tests. New clinical read-outs are needed to detect and identify the causative pathogen. These assays will be based on specific antigen detection in the urine or specific pathogen DNA detection in the blood. Technical and clinical validation of these assays will be realised at later stage with samples coming from epidemiological and/or phase III studies.

To allow the development of such tests in GSK Biologicals laboratories, urine and blood samples are needed from subjects aged 65 or above who have diagnosed pneumonia.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female aged 65 or above at the time of the study.
  • Written informed consent obtained from the subject.
  • Clinical pneumonia diagnosed by chest X-ray detected within 7 days before study entry.

Exclusion criteria

  • Vaccination with a pneumococcal or Haemophilus vaccine within the last 3 months before study entry.
  • Antibiotherapy started more than 7 days before Screening.
  • A negative culture for Streptococcus pneumoniae or Non-Typable Haemophilus influenza.
  • A urine sample at Screening less than 40 mL.

Treatment and study plan

Blood sample

Procedure

One blood sample will be collected at the time of screening for subjects

Urine sample

Procedure

One urine sample will be collected at the time of screening for subjects

Primary outcomes

  1. Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia.

    Time frame: At the time of analysis.

  2. Detection of Streptococcus pneumoniae DNA in the blood of subjects with diagnosed pneumonia.

    Time frame: At the time of analysis.

Secondary outcomes

  1. Detection of Non-Typable Haemophilus influenzae antigens in the urine of subjects with diagnosed pneumonia.

    Time frame: At the time of analysis.

  2. Detection of Non-Typable Haemophilus influenzae DNA in the blood of subjects with diagnosed pneumonia.

    Time frame: At the time of analysis.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Study to Collect Blood and Urine Samples in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 18, 2008
Registry last updated
Jan 13, 2014

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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