<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01730391</url>
  </required_header>
  <id_info>
    <org_study_id>114989</org_study_id>
    <nct_id>NCT01730391</nct_id>
  </id_info>
  <brief_title>Neisseria Meningitidis Burden of Disease Study</brief_title>
  <official_title>Neisseria Meningitidis Burden of Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      This study aims to provide an estimate of the proportion of suspected cases of bacterial&#xD;
      meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines&#xD;
      and Vietnam.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of N. meningitis in CSF samples</measure>
    <time_frame>At enrollment (Day 0)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serogroup of N. meningitis positive samples</measure>
    <time_frame>At enrollment (Day 0)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Further characterization of N. meningitidis using Multi Locus Sequence Typing</measure>
    <time_frame>At enrollment (Day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis</measure>
    <time_frame>At enrollment (Day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serotype of Streptococcus pneumoniae positive samples</measure>
    <time_frame>At enrollment (Day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Further classification of Haemophilus influenzae positive samples into Type B and non-B Types</measure>
    <time_frame>At enrollment (Day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of subjects with suspected bacterial meningitis (according to diagnostic criteria used by each participating hospital to identify this condition)</measure>
    <time_frame>At enrollment (Day 0)</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">521</enrollment>
  <condition>Streptococcus Pneumoniae</condition>
  <condition>Neisseria Meningitidis</condition>
  <condition>Haemophilus Influenzae</condition>
  <arm_group>
    <arm_group_label>Study cohort</arm_group_label>
    <description>Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Collection of demographic data and vaccination history</description>
    <arm_group_label>Study cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CSF samples testing</intervention_name>
    <description>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)</description>
    <arm_group_label>Study cohort</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cerebrospinal Fluid (CSF) sample (collected as part of routine practice)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and&#xD;
        Vietnam.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who the investigator believes can and will comply with the requirements of&#xD;
             the protocol or subjects who the investigator believes that parent(s)/Legally&#xD;
             Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the&#xD;
             protocol.&#xD;
&#xD;
          -  Written informed consent obtained from the subject/from the parent(s)/LAR of the&#xD;
             subject.&#xD;
&#xD;
          -  A male or female subject who visits the hospital with suspected bacterial meningitis.&#xD;
&#xD;
          -  CSF sample taken as part of routine practice.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child in care.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Baguio City, Benguet</city>
        <zip>2600</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Quezon City</city>
        <zip>1102</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hanoi</city>
        <zip>084</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 9, 2015</last_update_submitted>
  <last_update_submitted_qc>November 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia, Pneumococcal</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01730391
org study id: 114989
nct id: NCT01730391
lead sponsor: 
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.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Prevalence of N. meningitis in CSF samples
time frame: At enrollment (Day 0)
measure: Serogroup of N. meningitis positive samples
time frame: At enrollment (Day 0)
measure: Further characterization of N. meningitidis using Multi Locus Sequence Typing
time frame: At enrollment (Day 0)
measure: Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis
time frame: At enrollment (Day 0)
measure: Serotype of Streptococcus pneumoniae positive samples
time frame: At enrollment (Day 0)
measure: Further classification of Haemophilus influenzae positive samples into Type B and non-B Types
time frame: At enrollment (Day 0)
measure: 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)
arm group label: Study cohort
description: Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.
intervention type: Other
intervention name: Data collection
description: Collection of demographic data and vaccination history
arm group label: Study cohort
intervention type: Other
intervention name: CSF samples testing
description: 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)
arm group label: Study cohort
Cerebrospinal Fluid (CSF) sample (collected as part of routine practice)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
country: Philippines
country: Vietnam
responsible party type: Sponsor
mesh term: Pneumonia, Pneumococcal