Last updated: 11/03/2018 11:23:28
A study in elderly subjects with pneumonia to support the development of bacteriological diagnostic assays
GSK study ID
111074
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study to collect blood and urine samples in elderly subjects with pneumonia to support the development of bacteriological diagnostic assays
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia.
Timeframe: At the time of analysis.
Detection of Streptococcus pneumoniae DNA in the blood of subjects with diagnosed pneumonia.
Timeframe: At the time of analysis.
Secondary outcomes:
Detection of Non-Typable Haemophilus influenzae antigens in the urine of subjects with diagnosed pneumonia.
Timeframe: At the time of analysis.
Detection of Non-Typable Haemophilus influenzae DNA in the blood of subjects with diagnosed pneumonia.
Timeframe: At the time of analysis.
Interventions:
Enrollment:
21
Primary completion date:
2009-09-02
Observational study model:
Case-Only
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Infections, Streptococcal
Product
GSK324332A
Collaborators
Not applicable
Study date(s)
March 2008 to February 2009
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
No
- 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.
- Vaccination with a pneumococcal or Haemophilus vaccine within the last 3 months before study entry.
- Antibiotherapy started more than 7 days before Screening.
Inclusion and exclusion 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.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2009-09-02
Actual study completion date
2009-09-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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