Streptococcus PneumoniaeNCT01730391
Neisseria Meningitidis Burden of Disease Study
An observational study of Streptococcus Pneumoniae and Neisseria Meningitidis, run by GlaxoSmithKline at 3 sites in 2 countries.
Trial summary
This study aims to provide an estimate of the proportion of suspected cases of bacterial meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines and Vietnam. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Streptococcus Pneumoniae, Neisseria Meningitidis, Haemophilus Influenzae
- What is being tested?
- Data collection and CSF samples testing
- Type of treatment
- Vaccines
- How many people
- 521 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2013to Aug 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.
Who may be able to join
- Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
- A male or female subject who visits the hospital with suspected bacterial meningitis.
- CSF sample taken as part of routine practice.
Who cannot join
- Child in care.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Philippines2 sites
GSK Investigational Site
Baguio City, Benguet, 2600
GSK Investigational Site
Quezon City, 1102
About this study
Official title: Neisseria Meningitidis Burden of Disease
This study aims to provide an estimate of the proportion of suspected cases of bacterial meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines and Vietnam.
- Being tested
- Data collection, CSF samples testing
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Collection of demographic data and vaccination history
CSF samples testingOther
CSF samples will be tested for the determination of N. meningitidis and other likely bacterial pathogens that cause bacterial meningitis (S. pneumoniae and H. influenzae)
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam. Receives: Other: Data collection; Other: CSF samples testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of N. meningitis in CSF samples
Measured: At enrollment (Day 0)
Serogroup of N. meningitis positive samples
Measured: At enrollment (Day 0)
Secondary outcomes (5)
Further characterization of N. meningitidis using Multi Locus Sequence Typing
Measured: At enrollment (Day 0)
Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis
Measured: At enrollment (Day 0)
Serotype of Streptococcus pneumoniae positive samples
Measured: At enrollment (Day 0)
Further classification of Haemophilus influenzae positive samples into Type B and non-B Types
Measured: At enrollment (Day 0)
Total number of subjects with suspected bacterial meningitis (according to diagnostic criteria used by each participating hospital to identify this condition)
Measured: At enrollment (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus PneumoniaeStudies 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
- Cross-sectional
- Enrolment
- 521 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
- NCT01730391
- Sponsor's protocol ID
- 114989
- Status last verified
- Nov 2015
- First submitted
- 15 Nov 2012
- Last updated
- 11 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neisseria Meningitidis Burden of Disease
- ClinicalTrials.gov ID
- NCT01730391
- Acronym / sponsor ID
- 114989
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Nov 2012 (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.
This study aims to provide an estimate of the proportion of suspected cases of bacterial meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines and Vietnam.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Other: Data collection, Other: CSF samples testingSubjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.
Key inclusion criteria (4 listed)
- Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
- A male or female subject who visits the hospital with suspected bacterial meningitis.
- CSF sample taken as part of routine practice.
Key exclusion criteria (1 listed)
- Child in care.
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 |
|---|---|---|
| Data collectionCollection of demographic data and vaccination history | Other | Study cohort |
| CSF samples testingCSF samples will be tested for the determination of N. meningitidis and other likely bacterial pathogens that cause bacterial meningitis (S. pneumoniae and H. influenzae) | Other | Study cohort |
Primary outcome
Prevalence of N. meningitis in CSF samples
Time frame: At enrollment (Day 0)
Serogroup of N. meningitis positive samples
Time frame: At enrollment (Day 0)
5 secondary outcomes
Further characterization of N. meningitidis using Multi Locus Sequence Typing
Time frame: At enrollment (Day 0)
Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis
Time frame: At enrollment (Day 0)
Serotype of Streptococcus pneumoniae positive samples
Time frame: At enrollment (Day 0)
Further classification of Haemophilus influenzae positive samples into Type B and non-B Types
Time frame: At enrollment (Day 0)
Total number of subjects with suspected bacterial meningitis (according to diagnostic criteria used by each participating hospital to identify this condition)
Time frame: At enrollment (Day 0)
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 11 Nov 2015.
Related trials for Streptococcus Pneumoniae
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pneumoniae and Neisseria Meningitidis, run by GlaxoSmithKline at 3 sites in 2 countries.
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 1 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 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Philippines, Vietnam. 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?
Prevalence of N. meningitis in CSF samples (time frame: At enrollment (Day 0)). 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 11 Nov 2015.