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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00637351 |
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.
Condition | Intervention |
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Pneumonia Invasive Pneumococcal Diseases |
Procedure: Blood sample Procedure: Urine sample |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | A Study to Collect Blood and Urine Samples in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays. |
whole blood, urine samples
Estimated Enrollment: | 30 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
Group B
Subjects with diagnosed pneumonia & positive culture of non-typable haemophilus influenzae
|
Procedure: Blood sample
One blood sample will be collected at the time of screening for subjects
Procedure: Urine sample
One urine sample will be collected at the time of screening for subjects
|
Group A
Subjects with diagnosed pneumonia & positive culture of streptococcus pneumoniae
|
Procedure: Blood sample
One blood sample will be collected at the time of screening for subjects
Procedure: Urine sample
One urine sample will be collected at the time of screening for subjects
|
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Elderly subjects with diagnosed pneumonia
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Belgium | |
GSK Investigational Site | Recruiting |
Brussels, Belgium, 1200 | |
GSK Investigational Site | Completed |
Yvoir, Belgium, 5330 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111074 |
Study First Received: | March 10, 2008 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00637351 History of Changes |
Health Authority: | Belgium: Institutional Review Board |
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Pneumonia |
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Pneumonia |