Genetic Susceptibility to Listeriosis

NCT03357536 | Recruiting

• 2 other identifiers: 2014-31ID-RCB number : 2015-A01386-43
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Listeriosis

Outcome Measures

Primary Outcomes (1)

• 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

  10 years

Secondary Outcomes (1)

• Identification of a susceptibility factor associated with the most severe or atypical forms

  10 years

Study Arms (2)

Patients with Listeriosis

EXPERIMENTAL

Patients with Listeriosis. Human biological samples : * Blood sample * Skin biopsy * Saliva

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

Procedure: Human biological samples

Interventions

Human biological samples PROCEDURE

* Blood sample * Skin biopsy * Saliva

Patients with Listeriosis; Volunteers related with patients with Listeriosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Inability to consent

Sponsors & Collaborators

• Institut Pasteur: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Centre Médical de l'Institut Pasteur

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Listeriosis

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Marc Lecuit

  Institut Pasteur

  STUDY DIRECTOR

Central Study Contacts

Marc Lecuit

CONTACT

+33 1 40 61 34 20; marc.lecuit@pasteur.fr

Caroline Charlier-Woerther

CONTACT

+33 1 40 31 30 10; caroline.charlier@pasteur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 30, 2017
• Study Start: November 28, 2017
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)