Neisseria Meningitidis Burden of Disease Study

Neisseria Meningitidis Burden of Disease

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.

Study Overview

• Status: Completed
• Conditions: Haemophilus Influenzae; Neisseria Meningitidis; Streptococcus Pneumoniae
• Intervention / Treatment: Other: Data collection; Other: CSF samples testing

• Study Type: Observational
• Enrollment (Actual): 521

Contacts and Locations

Study Locations

• Philippines
  • Baguio City, Benguet, Philippines, 2600
    • GSK Investigational Site
  • Quezon City, Philippines, 1102
    • GSK Investigational Site
• Vietnam
  • Hanoi, Vietnam, 084
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study cohort; Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.	Other: Data collection; Collection of demographic data and vaccination history; 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)
Serotype of Streptococcus pneumoniae positive samples	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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: November 15, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Estimate): November 11, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia, Pneumococcal
• Other Study ID Numbers: 114989

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No