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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Infections, Streptococcal

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Subjects with diagnosed pneumonia \& positive culture of streptococcus pneumoniae

Blood sample

Intervention Type PROCEDURE

One blood sample will be collected at the time of screening for subjects

Urine sample

Intervention Type PROCEDURE

One urine sample will be collected at the time of screening for subjects

Group B

Subjects with diagnosed pneumonia \& positive culture of non-typable haemophilus influenzae

Blood sample

Intervention Type PROCEDURE

One blood sample will be collected at the time of screening for subjects

Urine sample

Intervention Type PROCEDURE

One urine sample will be collected at the time of screening for subjects

Interventions

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Blood sample

One blood sample will be collected at the time of screening for subjects

Intervention Type PROCEDURE

Urine sample

One urine sample will be collected at the time of screening for subjects

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No