ListeriosisListeria-GENNCT03357536
Genetic Susceptibility to Listeriosis
A study testing Human biological samples in people with Listeriosis, run by Institut Pasteur at 1 site in France.
Trial summary
Listeriosis is a rare, severe foodborne infection, responsible for severe invasive infections. It occurs in the great majority of cases in elderly patients and / or patients with comorbidities, with a deficit of innate or cellular immunity. Pregnancy is also a risk factor. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Listeriosis
- What is being tested?
- Human biological samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2017to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Microbiologically documented Listeriosis (either a severe form of listeriosis, or an atypical form of listeriosis, or less than 40 years old and without any co-morbidity identified)
- Affiliated or beneficiary of a social security system
- Informed and written consent
- Inclusion Criteria for volunteers related to patients with Listeriosis (after identifying a genetic susceptibility in the patient with Listeriosis) :
- defined as father, mother, brother (s), sister (s), child (ren), grandparent (s), uncle (s), aunt (s), cousin (s), nephew (s), niece (s).
- Affiliated or beneficiary of a social security system
Show all 9Show fewer
- Informed and written consent
- Exclusion Criteria for volunteers related to patients with Listeriosis:
- Inability to consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Médical de l'Institut Pasteur
Paris, 75015
Caroline Charlier-Woerther, MD, +33 1 40 61 30 10, caroline.charlier@pasteur.fr
About this study
Official title: Genetic Susceptibility to Listeriosis - Listeria-GEN
Listeriosis is a rare, severe foodborne infection, responsible for severe invasive infections. It occurs in the great majority of cases in elderly patients and / or patients with comorbidities, with a deficit of innate or cellular immunity. Pregnancy is also a risk factor.
The Multicentric Observational NAtional Analysis of Listeriosis and Listeria (MONALISA) is an ongoing national case-control prospective study on listeriosis implemented since 2009 to study risk and prognosis factors for listeriosis. In this cohort, which enrolled 902 patients on 1 August 2014, 7% of patients with neurolisteriosis are under 40 years of age and have no identified risk factor. Genetic susceptibility is suspected in these patients. Genetic susceptibility could also explain the inconstant development of a neurolisteriosis or fetal infection, as well as the particular severity of some infections (death, foetal loss, neurological sequelae).
The aim of the study is to identify genetic susceptibility to Listeriosis.
Read the detailed description
Listeriosis is a rare, severe foodborne infection caused by the bacterium Listeria monocytogenes (Lm), responsible for severe invasive infections. It occurs in the great majority of cases in elderly patients and / or patients with comorbidities, with a deficit of innate or cellular immunity. Pregnancy is also a risk factor.
The Multicentric Observational NAtional Analysis of Listeriosis and Listeria (MONALISA) is an ongoing national case-control prospective study on listeriosis implemented since 2009 to study risk and prognosis factors for listeriosis. In this cohort, which enrolled 902 patients on 1 August 2014, 7% of patients with neurolisteriosis are under 40 years of age and have no identified risk factor. Genetic susceptibility is suspected in these patients. Genetic susceptibility could also explain the inconstant development of a neurolisteriosis or fetal infection, as well as the particular severity of some infections (death, foetal loss, neurological sequelae).
The analysis of the genetically transmitted vulnerability of Lm has not yet been studied, because of the lack of accessibility to prospective cohorts (and their DNA) for this rare and severe infection.
The aim of the study is to identify genetic susceptibility to Listeriosis that will optimize the patient care in terms of treatment and prevention.
- Conditions
- Listeriosis
- Being tested
- Human biological samples
- Medical subject headings
- Listeriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human biological samplesProcedure or surgery
- Blood sample
- Skin biopsy
- Saliva
| Study group | Role | What they receive |
|---|---|---|
| Patients with Listeriosis | Experimental | Patients with Listeriosis.
Human biological samples :
* Blood sample
* Skin biopsy
* Saliva Receives: Procedure: Human biological samples |
| Volunteers related with patients with Listeriosis | Experimental | Volunteers related with patients with Listeriosis.
Human biological samples :
* Blood sample
* Skin biopsy
* Saliva Receives: Procedure: Human biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a susceptibility factor associated with Listeriosis infection
In patients with Listeriosis, the hypothesis that the identified genetic variation is the mutation responsible for the infection will be verified :
- by verifying that it is not a listed polymorphism by sequencing genomic DNA controls
- by verifiyng that family genetic segregation is compatible with clinical segregation
- by verifying the function of the mutated protein in the patient's cell lines and / or fresh cells
- by performing complementation experiments by transfecting the wild-type allele into the patient's cells
Measured: 10 years
Secondary outcomes (1)
Identification of a susceptibility factor associated with the most severe or atypical forms
In patients with Listeriosis, the susceptibility factor associated with the most severe or atypical forms will be characterized :
- By testing the response and production of cytokines involved in infection control.
- By identifying chromosomal regions associated with the disease by a homozygosity mapping genetic study on multiplex and / or inbred families.
- By sequencing the identified candidate genes.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start28 Nov 2017
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ListeriosisStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Marc Lecuit, Study director, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357536
- Sponsor's protocol ID
- 2014-31
- Other IDs
- ID-RCB number : 2015-A01386-43
- Acronym
- Listeria-GEN
- Status last verified
- Sep 2025
- First submitted
- 24 Nov 2017
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Susceptibility to Listeriosis - Listeria-GEN
- ClinicalTrials.gov ID
- NCT03357536
- Acronym / sponsor ID
- Listeria-GEN / 2014-31
- Conditions
- Listeriosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 30 Nov 2017 (actual)
- 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.
Listeriosis is a rare, severe foodborne infection, responsible for severe invasive infections. It occurs in the great majority of cases in elderly patients and / or patients with comorbidities, with a deficit of innate or cellular immunity. Pregnancy is also a risk factor.
The Multicentric Observational NAtional Analysis of Listeriosis and Listeria (MONALISA) is an ongoing national case-control prospective study on listeriosis implemented since 2009 to study risk and prognosis factors for listeriosis. In this cohort, which enrolled 902 patients on 1 August 2014, 7% of patients with neurolisteriosis are under 40 years of age and have no identified risk factor. Genetic susceptibility is suspected in these patients. Genetic susceptibility could also explain the inconstant development of a neurolisteriosis or fetal infection, as well as the particular severity of some infections (death, foetal loss, neurological sequelae).
The aim of the study is to identify genetic susceptibility to Listeriosis.
Detailed description
Listeriosis is a rare, severe foodborne infection caused by the bacterium Listeria monocytogenes (Lm), responsible for severe invasive infections. It occurs in the great majority of cases in elderly patients and / or patients with comorbidities, with a deficit of innate or cellular immunity. Pregnancy is also a risk factor.
The Multicentric Observational NAtional Analysis of Listeriosis and Listeria (MONALISA) is an ongoing national case-control prospective study on listeriosis implemented since 2009 to study risk and prognosis factors for listeriosis. In this cohort, which enrolled 902 patients on 1 August 2014, 7% of patients with neurolisteriosis are under 40 years of age and have no identified risk factor. Genetic susceptibility is suspected in these patients. Genetic susceptibility could also explain the inconstant development of a neurolisteriosis or fetal infection, as well as the particular severity of some infections (death, foetal loss, neurological sequelae).
The analysis of the genetically transmitted vulnerability of Lm has not yet been studied, because of the lack of accessibility to prospective cohorts (and their DNA) for this rare and severe infection.
The aim of the study is to identify genetic susceptibility to Listeriosis that will optimize the patient care in terms of treatment and prevention.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Listeriosis | Experimental | Procedure: Human biological samplesPatients with Listeriosis. Human biological samples : * Blood sample * Skin biopsy * Saliva |
| Volunteers related with patients with Listeriosis | Experimental | Procedure: Human biological samplesVolunteers related with patients with Listeriosis. Human biological samples : * Blood sample * Skin biopsy * Saliva |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Microbiologically documented Listeriosis (either a severe form of listeriosis, or an atypical form of listeriosis, or less than 40 years old and without any co-morbidity identified)
- Affiliated or beneficiary of a social security system
- Informed and written consent
- Inclusion Criteria for volunteers related to patients with Listeriosis (after identifying a genetic susceptibility in the patient with Listeriosis) :
- defined as father, mother, brother (s), sister (s), child (ren), grandparent (s), uncle (s), aunt (s), cousin (s), nephew (s), niece (s).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Human biological samples* Blood sample * Skin biopsy * Saliva | Procedure or surgery | Patients with Listeriosis, Volunteers related with patients with Listeriosis |
Primary outcome
Identification of a susceptibility factor associated with Listeriosis infection
Time frame: 10 years
In patients with Listeriosis, the hypothesis that the identified genetic variation is the mutation responsible for the infection will be verified : * by verifying that it is not a listed polymorphism by sequencing genomic DNA controls * by verifiyng that family genetic segregation is compatible with clinical segregation * by verifying the function of the mutated protein in the patient's cell lines and / or fresh cells * by performing complementation experiments by transfecting the wild-type allele into the patient's cells
1 secondary outcome
Identification of a susceptibility factor associated with the most severe or atypical forms
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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.
Marc Lecuit study director
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human biological samples in people with Listeriosis, run by Institut Pasteur at 1 site in France.
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 9 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Lecuit (+33 1 40 61 34 20, marc.lecuit@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a susceptibility factor associated with Listeriosis infection (time frame: 10 years). 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 19 Sep 2025.