Clinical trial NCT02727465: Host-pathogen Interactions in Meningococcal Disease: Finding the Key That Fits the Lock
Official title: Host-pathogen Interactions in Meningococcal Disease: Finding the Key That Fits the Lock
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Meningitis
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
First posted: 2016-04-04
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: informed consent obtained for all culture-confirmed IMD to sequence their genome.
timeFrame: up to 55 months
Secondary outcomes:
measure: creation of a functional database linking anonymised whole genome human and meningococcal sequences with data collected through national surveillance
timeFrame: up to 55 months
measure: detailed genetic analysis on human-pathogen pairs, focussing particularly on (but not restricted to) the human complement system and the respective meningococcal binding proteins.
timeFrame: up to 55 months
measure: visualising potential host-pathogen interactions through computer modelling
timeFrame: up to 55 months
Other outcomes:
Locations:
city: England
country: United Kingdom
facility: All NHS hospitals
Study officials:
affiliation: Public Health England
name: Shamez Ladhani, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: