Neisseria Meningitidis Burden of Disease Study

Neisseria Meningitidis Clinical Trial

Official title:

Neisseria Meningitidis Burden of Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730391
• Other study ID #: 114989
• Status: Completed
• Phase: N/A
• First received: November 15, 2012
• Last updated: November 9, 2015
• Start date: January 2013
• Est. completion date: August 2013

Study information

• Verified date: November 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Philippines Food and Drug AdministrationVietnam: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Haemophilus Influenzae
• Neisseria Meningitidis
• Streptococcus Pneumoniae

Intervention

Other:
• Data collection
Collection of demographic data and vaccination history
• 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)

Locations

Country	Name	City	State
Philippines	GSK Investigational Site	Baguio City, Benguet
Philippines	GSK Investigational Site	Quezon City
Vietnam	GSK Investigational Site	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Philippines,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of N. meningitis in CSF samples		At enrollment (Day 0)	No
Primary	Serogroup of N. meningitis positive samples		At enrollment (Day 0)	No
Secondary	Further characterization of N. meningitidis using Multi Locus Sequence Typing		At enrollment (Day 0)	No
Secondary	Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis		At enrollment (Day 0)	No
Secondary	Serotype of Streptococcus pneumoniae positive samples		At enrollment (Day 0)	No
Secondary	Further classification of Haemophilus influenzae positive samples into Type B and non-B Types		At enrollment (Day 0)	No
Secondary	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)	No