Neisseria Meningitidis Burden of Disease Study

NCT ID: NCT01730391

Last Updated: 2015-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

521 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Streptococcus Pneumoniae Neisseria Meningitidis Haemophilus Influenzae

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study cohort

Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.

Data collection

Intervention Type OTHER

Collection of demographic data and vaccination history

CSF samples testing

Intervention Type OTHER

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)

Interventions

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Data collection

Collection of demographic data and vaccination history

Intervention Type OTHER

CSF 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)

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Baguio City, Benguet, , Philippines

Site Status

GSK Investigational Site

Quezon City, , Philippines

Site Status

GSK Investigational Site

Hanoi, , Vietnam

Site Status

Countries

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Philippines Vietnam

Other Identifiers

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114989

Identifier Type: -

Identifier Source: org_study_id

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