Clinical Trials Directory

Trials / Completed

CompletedNCT00637351

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
21 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBlood sampleOne blood sample will be collected at the time of screening for subjects
PROCEDUREUrine sampleOne urine sample will be collected at the time of screening for subjects

Timeline

Start date
2008-03-01
Primary completion
2009-02-01
Completion
2009-02-01
First posted
2008-03-18
Last updated
2014-01-13

Locations

2 sites across 1 country: Belgium

Source: ClinicalTrials.gov record NCT00637351. Inclusion in this directory is not an endorsement.