Neisseria Meningitidis Burden of Disease Study

Completed

• Conditions: Neisseria Meningitidis; Streptococcus Pneumoniae; Haemophilus Influenzae
• Interventions: Other: Data collection; Other: CSF samples testing

• Registration Number: NCT01730391
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-21
• Study Start: 2013-01
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 521

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study cohort	CSF samples testing	Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.
Study cohort	Data collection	Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.

Primary Outcome Measures

Name	Time	Method
Serogroup of N. meningitis positive samples	At enrollment (Day 0)
Prevalence of N. meningitis in CSF samples	At enrollment (Day 0)

Secondary Outcome Measures

Name	Time	Method
Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis	At enrollment (Day 0)
Serotype of Streptococcus pneumoniae positive samples	At enrollment (Day 0)
Further characterization of N. meningitidis using Multi Locus Sequence Typing	At enrollment (Day 0)
Further classification of Haemophilus influenzae positive samples into Type B and non-B Types	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)	At enrollment (Day 0)

Trial Locations

Locations (1)

GSK Investigational Site; 🇻🇳 Hanoi, Vietnam