Host-pathogen Interactions in Meningococcal Disease: Finding the Key That Fits the Lock

Withdrawn

• Conditions: Meningitis
• Interventions: Other: Meningitis cases

• Registration Number: NCT02727465
• Lead Sponsor: Public Health England

Brief Summary

At any time, around 10% of people carry meningococcal bacteria in the nose and throat, which can cause meningitis, blood poisoning and other serious illnesses. Most people carry these bacteria and never become ill, yet a very small proportion go on to develop these illnesses which can result in life long disabilities or death. The mechanism by which this happens is poorly understood and has been studied in various ways, usually focussing on the bacteria or on the individual, but none has given a definitive answer. This study will be the first of its kind and will assess the interaction between the host and the bacteria at the genetic level, through genetic mapping, helping us to understand what makes some people susceptible to this infection.

Detailed Description

At any time, around 10% of people carry meningococcal bacteria in the nose and throat, which can cause meningitis, blood poisoning and other serious illnesses. Most people carry these bacteria and never become ill, yet a very small proportion go on to develop these illnesses which can result in life long disabilities or death. The mechanism by which this happens is poorly understood and has been studied in various ways, usually focussing on the bacteria or on the individual, but none has given a definitive answer. This study will be the first of its kind and will assess the interaction between the host and the bacteria at the genetic level, through genetic mapping, helping us to understand what makes some people susceptible to this infection.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-05
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• any individual with culture-confirmed IMD in England from 01 September 2015 to 31 August 2019
• written informed consent from the individual, the parent (for children aged <16 years) or next-of-kin (for non-survivors)

Exclusion Criteria

• any individual who does not fulfil the inclusion criteria

Temporary Exclusion Criteria:

• Critically-ill patients and/or their family member will be only approached when the patient starts recovering from their illness or after they are deceased, on the advice of their clinical team.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
meningitis cases	Meningitis cases	any individual with culture-confirmed IMD in England from 01 September 2015 to 31 August 2019 with written informed consent from the individual, the parent (for children aged \<16 years) or next-of-kin (for non-survivors)

Primary Outcome Measures

Name	Time	Method
informed consent obtained for all culture-confirmed IMD to sequence their genome.	up to 55 months	enrol cases

Secondary Outcome Measures

Name	Time	Method
creation of a functional database linking anonymised whole genome human and meningococcal sequences with data collected through national surveillance	up to 55 months	construction of reference database
detailed genetic analysis on human-pathogen pairs, focussing particularly on (but not restricted to) the human complement system and the respective meningococcal binding proteins.	up to 55 months	Genetic analysis
visualising potential host-pathogen interactions through computer modelling	up to 55 months	computer modelling

Trial Locations

Locations (1)

All NHS hospitals; 🇬🇧 England, United Kingdom