Infections, Streptococcal
Conditions
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.
Interventions
PROCEDUREBlood sample
One blood sample will be collected at the time of screening for subjects
PROCEDUREUrine sample
One urine sample will be collected at the time of screening for subjects
Sponsors
GlaxoSmithKline
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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. |
Countries
Belgium
Outcome results
None listed