Genetic Susceptibility to Listeriosis

NCT ID: NCT03357536

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2027-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Listeriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Listeriosis

Patients with Listeriosis.

Human biological samples :

* Blood sample
* Skin biopsy
* Saliva

Group Type EXPERIMENTAL

Human biological samples

Intervention Type PROCEDURE

* Blood sample
* Skin biopsy
* Saliva

Volunteers related with patients with Listeriosis

Volunteers related with patients with Listeriosis.

Human biological samples :

* Blood sample
* Skin biopsy
* Saliva

Group Type EXPERIMENTAL

Human biological samples

Intervention Type PROCEDURE

* Blood sample
* Skin biopsy
* Saliva

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Human biological samples

* Blood sample
* Skin biopsy
* Saliva

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Inability to consent
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marc Lecuit

Role: STUDY_DIRECTOR

Institut Pasteur

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Médical de l'Institut Pasteur

Paris, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marc Lecuit

Role: CONTACT

+33 1 40 61 34 20

Caroline Charlier-Woerther

Role: CONTACT

+33 1 40 31 30 10

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Caroline Charlier-Woerther, MD

Role: primary

+33 1 40 61 30 10

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ID-RCB number : 2015-A01386-43

Identifier Type: OTHER

Identifier Source: secondary_id

2014-31

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pediatric Reporting of Adult-Onset Genomic Results
NCT03832985 COMPLETED EARLY_PHASE1
Study of Gene Associations and Infertility
NCT01223092 ENROLLING_BY_INVITATION
Genetic Studies of Lysosomal Storage Disorders
NCT00001215 ENROLLING_BY_INVITATION