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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00637351
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date March 10, 2008
First Posted Date March 18, 2008
Last Update Posted Date January 13, 2014
Study Start Date March 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 4, 2013)
  • Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ]
  • Detection of Streptococcus pneumoniae DNA in the blood of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ]
Original Primary Outcome Measures
 (submitted: March 17, 2008)
  • Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia.
  • Detection of Streptococcus pneumoniae DNA in the blood of subjects with diagnosed pneumonia.
Change History Complete list of historical versions of study NCT00637351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 4, 2013)
  • Detection of Non-Typable Haemophilus influenzae antigens in the urine of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ]
  • Detection of Non-Typable Haemophilus influenzae DNA in the blood of subjects with diagnosed pneumonia. [ Time Frame: At the time of analysis. ]
Original Secondary Outcome Measures
 (submitted: March 17, 2008)
  • Detection of Non-Typable Haemophilus influenzae antigens in the urine of subjects with diagnosed pneumonia.
  • Detection of Non-Typable Haemophilus influenzae DNA in the blood of subjects with diagnosed pneumonia.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays
Official Title A Study to Collect Blood and Urine Samples in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, urine samples
Sampling Method Probability Sample
Study Population Elderly subjects with diagnosed pneumonia
Condition Infections, Streptococcal
Intervention
  • 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
Study Groups/Cohorts
  • Group A
    Subjects with diagnosed pneumonia & positive culture of streptococcus pneumoniae
    Interventions:
    • Procedure: Blood sample
    • Procedure: Urine sample
  • Group B
    Subjects with diagnosed pneumonia & positive culture of non-typable haemophilus influenzae
    Interventions:
    • Procedure: Blood sample
    • Procedure: Urine sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 26, 2012)
21
Original Estimated Enrollment
 (submitted: March 17, 2008)
40
Actual Study Completion Date February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT00637351
Other Study ID Numbers 111074
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date January 2014