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Completed

NCT Number: NCT01730391

Neisseria Meningitidis Burden of Disease Study

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.

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Key information

Conditions

Streptococcus Pneumoniae Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Haemophilus Influenzae Infections Neisseria Meningitidis Pasteurellaceae Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Baguio City, Benguet, Philippines

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

Collection of demographic data and vaccination history

CSF samples testing

Other

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)

Primary outcomes

  1. Prevalence of N. meningitis in CSF samples

    Time frame: At enrollment (Day 0)

  2. Serogroup of N. meningitis positive samples

    Time frame: At enrollment (Day 0)

Secondary outcomes

  1. Further characterization of N. meningitidis using Multi Locus Sequence Typing

    Time frame: At enrollment (Day 0)

  2. Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis

    Time frame: At enrollment (Day 0)

  3. Serotype of Streptococcus pneumoniae positive samples

    Time frame: At enrollment (Day 0)

  4. Further classification of Haemophilus influenzae positive samples into Type B and non-B Types

    Time frame: At enrollment (Day 0)

  5. 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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Neisseria Meningitidis Burden of Disease

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2012
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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