MeningitisLock and KeyNCT02727465
Host-pathogen Interactions in Meningococcal Disease: Finding the Key That Fits the Lock
An observational study of Meningitis, run by Public Health England at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meningitis
- What is being tested?
- Meningitis cases
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Meningitis
- Being tested
- Meningitis cases
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningitis casesOther
None - blood draw only
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Meningitis cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
informed consent obtained for all culture-confirmed IMD to sequence their genome.
enrol cases
Measured: 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
construction of reference database
Measured: 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.
Genetic analysis
Measured: up to 55 months
visualising potential host-pathogen interactions through computer modelling
computer modelling
Measured: up to 55 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shamez Ladhani, MD PhD, Principal investigator, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727465
- Sponsor's protocol ID
- Lock and Key
- Acronym
- Lock and Key
- Status last verified
- Apr 2017
- First submitted
- 9 Mar 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host-pathogen Interactions in Meningococcal Disease: Finding the Key That Fits the Lock
- ClinicalTrials.gov ID
- NCT02727465
- Acronym / sponsor ID
- Lock and Key / Lock and Key
- Conditions
- Meningitis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Mar 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| meningitis cases | – | Other: Meningitis casesany 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- any individual who does not fulfil the inclusion 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meningitis casesNone - blood draw only | Other | meningitis cases |
Primary outcome
informed consent obtained for all culture-confirmed IMD to sequence their genome.
Time frame: up to 55 months
enrol cases
3 secondary outcomes
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
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
visualising potential host-pathogen interactions through computer modelling
Time frame: up to 55 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Meningitis
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 4
Aciclovir Versus Placebo for HSV-2 Meningitis
Herpes Simplex 2, Meningitis, Viral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamez Ladhani, MD PhD principal investigator
Public Health England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis, run by Public Health England at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
informed consent obtained for all culture-confirmed IMD to sequence their genome. (time frame: up to 55 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.