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Genetic Susceptibility to Listeriosis (Listeria-GEN)

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Pasteur Institute

Status

Enrolling

Conditions

Listeriosis

Treatments

Procedure: Human biological samples

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03357536
ID-RCB number : 2015-A01386-43 (Other Identifier)
2014-31

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Patients with Listeriosis
Experimental group
Description:
Patients with Listeriosis. Human biological samples : * Blood sample * Skin biopsy * Saliva
Treatment:
Procedure: Human biological samples
Volunteers related with patients with Listeriosis
Experimental group
Description:
Volunteers related with patients with Listeriosis. Human biological samples : * Blood sample * Skin biopsy * Saliva
Treatment:
Procedure: Human biological samples

Trial contacts and locations

1

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Central trial contact

Marc Lecuit; Caroline Charlier-Woerther

Data sourced from clinicaltrials.gov

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