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Genetic Susceptibility to Listeriosis (Listeria-GEN)

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ClinicalTrials.gov Identifier: NCT03357536
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : January 12, 2024
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Institut Pasteur

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Listeriosis Procedure: Human biological samples Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Genetic Susceptibility to Listeriosis - Listeria-GEN
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : November 30, 2027
Estimated Study Completion Date : November 30, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with Listeriosis

Patients with Listeriosis.

Human biological samples :

  • Blood sample
  • Skin biopsy
  • Saliva
 Procedure: Human biological samples
  • Blood sample
  • Skin biopsy
  • Saliva
Experimental: Volunteers related with patients with Listeriosis

Volunteers related with patients with Listeriosis.

Human biological samples :

  • Blood sample
  • Skin biopsy
  • Saliva
 Procedure: Human biological samples
  • Blood sample
  • Skin biopsy
  • Saliva


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Identification of a susceptibility factor associated with the most severe or atypical forms [ Time Frame: 10 years ]

    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for patients with Listeriosis :

  • 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
  • Informed and written consent

Exclusion Criteria for volunteers related to patients with Listeriosis:

  • Inability to consent
Contacts and Locations
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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): NCT03357536


Contacts
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Contact: Marc Lecuit +33 1 40 61 34 20 marc.lecuit@pasteur.fr
Contact: Caroline Charlier-Woerther +33 1 40 31 30 10 caroline.charlier@pasteur.fr

Locations
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France
Centre Médical de l'Institut Pasteur Recruiting
Paris, France, 75015
Contact: Caroline Charlier-Woerther, MD    +33 1 40 61 30 10    caroline.charlier@pasteur.fr   
Sponsors and Collaborators
Institut Pasteur
Icahn School of Medicine at Mount Sinai
Investigators
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Study Director: Marc Lecuit Institut Pasteur
More Information
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03357536    
Other Study ID Numbers: 2014-31
ID-RCB number : 2015-A01386-43 ( Other Identifier: French national registration number of the study )
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: January 12, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Listeriosis
Genetic Predisposition to Disease
Disease Susceptibility
Disease Attributes
Pathologic Processes
 Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections