Infections, StreptococcalNCT00637351
A Study in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays
An observational study of Infections, Streptococcal, run by GlaxoSmithKline at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Blood sample and Urine sample
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 2 sitesBelgium
- Study dates
- Mar 2008to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly subjects with diagnosed pneumonia
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Belgium2 sites
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Yvoir, 5330
About this study
Official title: 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.
- Conditions
- Infections, Streptococcal
- Being tested
- Blood sample, Urine sample
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
One blood sample will be collected at the time of screening for subjects
Urine sampleProcedure or surgery
One urine sample will be collected at the time of screening for subjects
| Study group | Role | What they receive |
|---|---|---|
| Group A | Subjects with diagnosed pneumonia \& positive culture of streptococcus pneumoniae Receives: Procedure: Blood sample; Procedure: Urine sample | |
| Group B | Subjects with diagnosed pneumonia \& positive culture of non-typable haemophilus influenzae Receives: Procedure: Blood sample; Procedure: Urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia.
Measured: At the time of analysis.
Detection of Streptococcus pneumoniae DNA in the blood of subjects with diagnosed pneumonia.
Measured: At the time of analysis.
Secondary outcomes (2)
Detection of Non-Typable Haemophilus influenzae antigens in the urine of subjects with diagnosed pneumonia.
Measured: At the time of analysis.
Detection of Non-Typable Haemophilus influenzae DNA in the blood of subjects with diagnosed pneumonia.
Measured: At the time of analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, StreptococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637351
- Sponsor's protocol ID
- 111074
- Status last verified
- Jan 2014
- First submitted
- 10 Mar 2008
- Last updated
- 13 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Collect Blood and Urine Samples in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays
- ClinicalTrials.gov ID
- NCT00637351
- Acronym / sponsor ID
- 111074
- Conditions
- Infections, Streptococcal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Blood sample, Procedure: Urine sampleSubjects with diagnosed pneumonia \& positive culture of streptococcus pneumoniae |
| Group B | – | Procedure: Blood sample, Procedure: Urine sampleSubjects with diagnosed pneumonia \& positive culture of non-typable haemophilus influenzae |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly subjects with diagnosed pneumonia
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleOne blood sample will be collected at the time of screening for subjects | Procedure or surgery | Group A, Group B |
| Urine sampleOne urine sample will be collected at the time of screening for subjects | Procedure or surgery | Group A, Group B |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Streptococcal, run by GlaxoSmithKline at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia. (time frame: At the time of analysis.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014.