Neisseria Meningitidis Burden of Disease Study | NCT01730391

Studies
Neisseria Meningitidis Burden of Disease Study

NCT01730391

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Nov 11, 2015Estimated

Enrollment

521Actual

Phase

Not provided

Conditions

Streptococcus Pneumoniae
Neisseria Meningitidis
Haemophilus Influenzae

Interventions

Data collection
CSF samples testing

Countries

Philippines
Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Nov 15, 2012

First Submission Date that Met QC Criteria

Nov 15, 2012

First Posted Date

Nov 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2015

Last Update Posted Date

Nov 11, 2015Estimated

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

521Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study cohort		Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.	Other: Data collection Other: CSF samples testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	Collection of demographic data and vaccination history	Study cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of N. meningitis in CSF samples		At enrollment (Day 0)
Serogroup of N. meningitis positive samples		At enrollment (Day 0)

Secondary Outcomes

Measure	Description	Time Frame
Further characterization of N. meningitidis using Multi Locus Sequence Typing		At enrollment (Day 0)
Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis		At enrollment (Day 0)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Baguio City, Benguet		2600	Philippines
GSK Investigational Site

Condition Browse Module

MeSH Terms

ID	Term
D006192	Haemophilus Infections

Ancestor Terms

ID	Term
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided