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Neisseria Meningitidis Burden of Disease Study

Neisseria Meningitidis Burden of Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01730391
Enrollment
521
Registered
2012-11-21
Start date
2013-01-31
Completion date
2013-08-31
Last updated
2015-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilus Influenzae, Neisseria Meningitidis, Streptococcus Pneumoniae

Brief 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.

Interventions

OTHERData collection

Collection of demographic data and vaccination history

OTHERCSF samples testing

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)

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Prevalence of N. meningitis in CSF samplesAt enrollment (Day 0)
Serogroup of N. meningitis positive samplesAt enrollment (Day 0)

Secondary

MeasureTime frame
Serotype of Streptococcus pneumoniae positive samplesAt enrollment (Day 0)
Further characterization of N. meningitidis using Multi Locus Sequence TypingAt enrollment (Day 0)
Total number of subjects with suspected bacterial meningitis (according to diagnostic criteria used by each participating hospital to identify this condition)At enrollment (Day 0)
Further classification of Haemophilus influenzae positive samples into Type B and non-B TypesAt enrollment (Day 0)
Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitisAt enrollment (Day 0)

Countries

Philippines, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026