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

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ClinicalTrials.gov Identifier: NCT00637351
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment
Infections, Streptococcal Procedure: Blood sample Procedure: Urine sample

Study Design

Study Type : Observational
Actual Enrollment : 21 participants
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
Study Start Date : March 2008
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ]
  2. Detection of Streptococcus pneumoniae DNA in the blood of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ]

Secondary Outcome Measures :
  1. Detection of Non-Typable Haemophilus influenzae antigens in the urine of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ]
  2. Detection of Non-Typable Haemophilus influenzae DNA in the blood of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ]

Biospecimen Retention:   Samples With DNA
whole blood, urine samples

Eligibility Criteria

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637351


Locations
Belgium
GSK Investigational Site
Brussels, Belgium, 1200
GSK Investigational Site
Yvoir, Belgium, 5330
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00637351     History of Changes
Other Study ID Numbers: 111074
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Pneumonia
Streptococcal Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Positive Bacterial Infections
Bacterial Infections