Last updated: 11/03/2018 17:28:23
Neisseria meningitidis burden of disease study
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Neisseria meningitidis burden of disease
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Prevalence of N. meningitis in CSF samples
Timeframe: At enrollment (Day 0)
Serogroup of N. meningitis positive samples
Timeframe: At enrollment (Day 0)
Secondary outcomes:
Further characterization of N. meningitidis using Multi Locus Sequence Typing
Timeframe: At enrollment (Day 0)
Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis
Timeframe: At enrollment (Day 0)
Serotype of Streptococcus pneumoniae positive samples
Timeframe: At enrollment (Day 0)
Further classification of Haemophilus influenzae positive samples into Type B and non-B Types
Timeframe: 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)
Timeframe: At enrollment (Day 0)
Interventions:
Other: Data collection
Other: CSF samples testing
Enrollment:
521
Observational study model:
Case-Only
Primary completion date:
2013-30-08
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Streptococcus pneumoniae, Neisseria Meningitidis, Haemophilus influenzae
Product
GSK2647155A
Collaborators
Not applicable
Study date(s)
January 2013 to August 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- 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.
- Child in care.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- Child in care.
Trial location(s)
Location
GSK Investigational Site
Baguio City, Benguet, Philippines, 2600
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2013-30-08
Actual study completion date
2013-30-08
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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