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

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.

Study Overview

• Status: Completed
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Procedure: Blood sample; Procedure: Urine sample

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • GSK Investigational Site
  • Yvoir, Belgium, 5330
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Elderly subjects with diagnosed pneumonia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Subjects with diagnosed pneumonia & positive culture of streptococcus pneumoniae	Procedure: Blood sample; One blood sample will be collected at the time of screening for subjects; Procedure: Urine sample; 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	Procedure: Blood sample; One blood sample will be collected at the time of screening for subjects; Procedure: Urine sample; One urine sample will be collected at the time of screening for subjects

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: March 10, 2008
• First Submitted That Met QC Criteria: March 17, 2008
• First Posted (Estimate): March 18, 2008

Study Record Updates

• Last Update Posted (Estimate): January 13, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Pneumonia; Streptococcal Infections
• Other Study ID Numbers: 111074