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Trial record 44 of 577 for:    meningitis

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

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ClinicalTrials.gov Identifier: NCT02727465
Recruitment Status : Withdrawn
First Posted : April 4, 2016
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Meningitis Other: Meningitis cases

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Host-pathogen Interactions in Meningococcal Disease: Finding the Key That Fits the Lock
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
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
None - blood draw only




Primary Outcome Measures :
  1. informed consent obtained for all culture-confirmed IMD to sequence their genome. [ Time Frame: up to 55 months ]
    enrol cases


Secondary Outcome Measures :
  1. creation of a functional database linking anonymised whole genome human and meningococcal sequences with data collected through national surveillance [ Time Frame: up to 55 months ]
    construction of reference database

  2. detailed genetic analysis on human-pathogen pairs, focussing particularly on (but not restricted to) the human complement system and the respective meningococcal binding proteins. [ Time Frame: up to 55 months ]
    Genetic analysis

  3. visualising potential host-pathogen interactions through computer modelling [ Time Frame: up to 55 months ]
    computer modelling


Biospecimen Retention:   Samples With DNA
DNA of bacteria and cases


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727465


Locations
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United Kingdom
All NHS hospitals
England, United Kingdom
Sponsors and Collaborators
Public Health England
Investigators
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Principal Investigator: Shamez Ladhani, MD PhD Public Health England

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Responsible Party: Public Health England
ClinicalTrials.gov Identifier: NCT02727465     History of Changes
Other Study ID Numbers: Lock and Key
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Meningitis
Meningococcal Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections