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Neisseria Meningitidis Burden of Disease Study

This study is not yet open for participant recruitment.
Verified May 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01730391
First received: November 15, 2012
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine
 Other: Data collection
Other: CSF samples testing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Neisseria Meningitidis Burden of Disease

Resource links provided by NLM:

Drug Information available for: Neisseria
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Prevalence of N. meningitis in CSF samples [ Time Frame: At enrollment (Day 0) ] [ Designated as safety issue: No ]
  • Serogroup of N. meningitis positive samples [ Time Frame: At enrollment (Day 0) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Further characterization of N. meningitidis using Multi Locus Sequence Typing [ Time Frame: At enrollment (Day 0) ] [ Designated as safety issue: No ]
  • Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis [ Time Frame: At enrollment (Day 0) ] [ Designated as safety issue: No ]
  • Serotype of Streptococcus pneumoniae positive samples [ Time Frame: At enrollment (Day 0) ] [ Designated as safety issue: No ]
  • Further classification of Haemophilus influenzae positive samples into Type B and non-B Types [ Time Frame: At enrollment (Day 0) ] [ Designated as safety issue: No ]
  • Total number of subjects with suspected bacterial meningitis (according to diagnostic criteria used by each participating hospital to identify this condition) [ Time Frame: At enrollment (Day 0) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Cerebrospinal Fluid (CSF) sample (collected as part of routine practice)


Estimated Enrollment: 1000
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730391

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Philippines
GSK Investigational Site Recruiting
Baguio City, Benguet, Philippines, 2600
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
GSK Investigational Site Not yet recruiting
Quezon City, Philippines, 1102
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
Vietnam
GSK Investigational Site Recruiting
Hanoi, Vietnam, 084
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01730391     History of Changes
Other Study ID Numbers: 114989
Study First Received: November 15, 2012
Last Updated: May 9, 2013
Health Authority: Philippines: Philippines Food and Drug Administration
Vietnam: Ministry of Health

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013