Infections, StreptococcalNCT00523770
Exploratory Study in Healthy Elderly Subjects to Collect Urine for Development of Assays to Detect S. Pneumoniae
An observational study of Infections, Streptococcal, run by GlaxoSmithKline.
Trial summary
GSK Biologicals is working on the development of a vaccine to protect elderly people from pneumococcal infection. For the future studies in that project, it would be useful to have some easy non invasive tests to detect infection by the bacteria. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Urine sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Sep 2007
- 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
- Healthy volunteers accepted
- Older adult
Study population: Residents of Belgium and Finland
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 between, and including, 65 and 85 years of age at the time of the study.
- Written informed consent obtained from the subject
- Healthy subjects as established by medical history and clinical examination before entering into the study
Who cannot join
- Previous vaccination against Streptococcus pneumoniae in the 3 months before study start,
- History of pneumonia confirmed by documented radiology or any other diagnostic method within 3 months prior to study start
About this study
Official title: An Exploratory Study in Healthy Elderly Subjects to Collect Urine for the Development of Assays to Detect Streptococcus Pneumoniae.
GSK Biologicals is working on the development of a vaccine to protect elderly people from pneumococcal infection. For the future studies in that project, it would be useful to have some easy non invasive tests to detect infection by the bacteria. Some tests on urine are already on the market but need to be improved in the laboratory. For that purpose, some urine samples from healthy subjects aged 65 years or above and who have not suffered from pneumonia nor have been administered pneumococcal vaccination in the past 3 months are needed.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
- Conditions
- Infections, Streptococcal
- Being tested
- Urine sample collection
- Keywords
- Invasive Pneumococcal Diseases, Pneumonia
- Medical subject headings
- Streptococcal Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine sample collectionProcedure or surgery
Urine samples will be collected and tested for the presence of S. pneumoniae
| Study group | Role | What they receive |
|---|---|---|
| Group A | Non-pneumococcal infected healthy elderly volunteers Receives: Procedure: Urine sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive or negative result using Binax NOW S. pneumoniae Test
Measured: within one day
Secondary outcomes (2)
Positive or negative result using the test to be developed for typing of S. pneumoniae
Measured: within one day
Positive or negative result using the test to be developed for detection of non-typable Haemophilus influenzae (NTHi)
Measured: within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2007
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT00523770
- Sponsor's protocol ID
- BACDU-001
- Status last verified
- Feb 2017
- First submitted
- 30 Aug 2007
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study in Healthy Elderly Subjects to Collect Urine for the Development of Assays to Detect Streptococcus Pneumoniae.
- ClinicalTrials.gov ID
- NCT00523770
- Acronym / sponsor ID
- BACDU-001
- Conditions
- Infections, Streptococcal
- Keywords
- Invasive Pneumococcal Diseases, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2007 (actual)
- First posted
- 31 Aug 2007 (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 pneumococcal infection. For the future studies in that project, it would be useful to have some easy non invasive tests to detect infection by the bacteria. Some tests on urine are already on the market but need to be improved in the laboratory. For that purpose, some urine samples from healthy subjects aged 65 years or above and who have not suffered from pneumonia nor have been administered pneumococcal vaccination in the past 3 months are needed.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Urine sample collectionNon-pneumococcal infected healthy elderly volunteers |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Residents of Belgium and Finland
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 between, and including, 65 and 85 years of age at the time of the study.
- Written informed consent obtained from the subject
- Healthy subjects as established by medical history and clinical examination before entering into the study
Key exclusion criteria (2 listed)
- Previous vaccination against Streptococcus pneumoniae in the 3 months before study start,
- History of pneumonia confirmed by documented radiology or any other diagnostic method within 3 months prior to study start
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 |
|---|---|---|
| Urine sample collectionUrine samples will be collected and tested for the presence of S. pneumoniae | Procedure or surgery | Group A |
Primary outcome
Positive or negative result using Binax NOW S. pneumoniae Test
Time frame: within one day
2 secondary outcomes
Positive or negative result using the test to be developed for typing of S. pneumoniae
Time frame: within one day
Positive or negative result using the test to be developed for detection of non-typable Haemophilus influenzae (NTHi)
Time frame: within one day
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 9 Feb 2017.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Streptococcal, run by GlaxoSmithKline.
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 2 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Positive or negative result using Binax NOW S. pneumoniae Test (time frame: within one day). 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 9 Feb 2017.