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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infections, Streptococcal

Intervention / Treatment
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* Procedure: Blood sample
* Procedure: Urine sample


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Subjects with diagnosed pneumonia & positive culture of streptococcus pneumoniae | Procedure: Blood sample<br>* One blood sample will be collected at the time of screening for subjects<br>Procedure: Urine sample<br>* One urine sample will be collected at the time of screening for subjects<br>|
| Group B<br>Subjects with diagnosed pneumonia & positive culture of non-typable haemophilus influenzae | Procedure: Blood sample<br>* One blood sample will be collected at the time of screening for subjects<br>Procedure: Urine sample<br>* One urine sample will be collected at the time of screening for subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia. |  | At the time of analysis. | 
| Detection of Streptococcus pneumoniae DNA in the blood of subjects with diagnosed pneumonia. |  | At the time of analysis. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Non-Typable Haemophilus influenzae antigens in the urine of subjects with diagnosed pneumonia. |  | At the time of analysis. | 
| Detection of Non-Typable Haemophilus influenzae DNA in the blood of subjects with diagnosed pneumonia. |  | At the time of analysis. |