Genetic Susceptibility to Listeriosis

ConditionListeriosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorInstitut Pasteur

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

Inability to consent

Trial design

Design model

Single group

Treatments tested in this trial

Human biological samples
Procedure/Surgery
* Blood sample * Skin biopsy * Saliva

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Patients with ListeriosisExperimental treatment 1 intervention

Group B: Volunteers related with patients with ListeriosisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

10 years

Secondary outcomes

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.

Time frame

10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Pasteur

Lead sponsor

Icahn School of Medicine at Mount Sinai

Collaborator

Source ClinicalTrials.gov

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