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

NCT02727465 | Withdrawn

• 1 other identifier: Lock and Key
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningitis

Outcome Measures

Primary Outcomes (1)

• informed consent obtained for all culture-confirmed IMD to sequence their genome.

  enrol cases

  up to 55 months

Secondary Outcomes (3)

• creation of a functional database linking anonymised whole genome human and meningococcal sequences with data collected through national surveillance

  up to 55 months

• 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

• visualising potential host-pathogen interactions through computer modelling

  up to 55 months

Study Arms (1)

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)

Other: Meningitis cases

Interventions

Meningitis cases OTHER

None - blood draw only

meningitis cases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Public Health England: lead

Study Sites (1)

All NHS hospitals

England, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA of bacteria and cases

MeSH Terms

Conditions

Meningitis

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Study Officials

• Shamez Ladhani, MD PhD

  Public Health England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: April 4, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 5, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)