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

Infections, Streptococcal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637351
• Other study ID #: 111074
• Status: Completed
• Phase: N/A
• First received: March 10, 2008
• Last updated: January 9, 2014
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: January 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infections, Streptococcal
• Streptococcal Infections

Intervention

Procedure:
• Blood sample
One blood sample will be collected at the time of screening for subjects
• Urine sample
One urine sample will be collected at the time of screening for subjects

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia.		At the time of analysis.	No
Primary	Detection of Streptococcus pneumoniae DNA in the blood of subjects with diagnosed pneumonia.		At the time of analysis.	No
Secondary	Detection of Non-Typable Haemophilus influenzae antigens in the urine of subjects with diagnosed pneumonia.		At the time of analysis.	No
Secondary	Detection of Non-Typable Haemophilus influenzae DNA in the blood of subjects with diagnosed pneumonia.		At the time of analysis.	No