Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT00637351
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2008-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Study to Collect Blood and Urine Samples in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: