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

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Infections, Streptococcal

Treatments

Procedure: Blood sample

Procedure: Urine sample

Study type

Observational

Funder types

Industry

Identifiers

NCT00637351

111074

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.