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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Subjects with diagnosed pneumonia & positive culture of streptococcus pneumoniae |
| |
| Group B | Subjects with diagnosed pneumonia & positive culture of non-typable haemophilus influenzae |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Procedure | One blood sample will be collected at the time of screening for subjects |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Elderly subjects with diagnosed pneumonia
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brussels | 1200 | Belgium | |||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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whole blood, urine samples
| Urine sample | Procedure | One urine sample will be collected at the time of screening for subjects |
|
| Yvoir |
| 5330 |
| Belgium |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |