A Study in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays - Full Text View

Purpose

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.

Condition	Intervention
Pneumonia, Bacterial	Procedure: Blood sample Procedure: Urine sample

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	A Study to Collect Blood and Urine Samples in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays

Resource links provided by NLM:

MedlinePlus related topics: Flu Pneumonia Urine and Urination

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]
Detection of Streptococcus pneumoniae DNA in the blood of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Detection of Non-Typable Haemophilus influenzae antigens in the urine of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]
Detection of Non-Typable Haemophilus influenzae DNA in the blood of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

whole blood, urine samples

Enrollment:	21
Study Start Date:	March 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Elderly subjects with diagnosed pneumonia

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637351

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00637351 History of Changes
Other Study ID Numbers:	111074
Study First Received:	March 10, 2008
Last Updated:	May 2, 2013
Health Authority:	Belgium: Institutional Review Board

Additional relevant MeSH terms:

Pneumonia, Bacterial
Pneumonia
Bacterial Infections

Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 23, 2013