NCT01730391

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
521

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

7 months

First QC Date

November 15, 2012

Last Update Submit

November 9, 2015

Conditions

Streptococcus PneumoniaeNeisseria MeningitidisHaemophilus Influenzae

Outcome Measures

Primary Outcomes (2)

  • Prevalence of N. meningitis in CSF samples

    At enrollment (Day 0)

  • Serogroup of N. meningitis positive samples

    At enrollment (Day 0)

Secondary Outcomes (5)

  • 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)

Study Arms (1)

Study cohort

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

Other: Data collectionOther: CSF samples testing

Interventions

Data collectionOTHER

Collection of demographic data and vaccination history

Study cohort
CSF samples testingOTHER

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)

Study cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Child in care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

Baguio City, Benguet, 2600, Philippines

Location

GSK Investigational Site

Quezon City, 1102, Philippines

Location

GSK Investigational Site

Hanoi, 084, Vietnam

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Haemophilus Infections

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pasteurellaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

January 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

VN(1)PH(2)