National Study on Listeriosis and Listeria (MONALISA)

January 18, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Multicentric Observational NAtional Study on LISteriosis and ListeriA

Listeriosis is a foodborne infection responsible for severe disease. Three main forms are described: septicaemia, central nervous system infections and maternal-fetal infections. Available data on the disease, are mostly retrospective and do not provide an accurate picture of the clinical / biological / genetic risk factors for the disease, nor identify any element to determine which patients are at higher risk of death, severe neurological impairment or fetal loss.

The primary purpose of the study is to identify clinical, biological and genetic risk factors for systemic listeriosis and the determinants of listeriosis-associated mortality in the setting of a large prospective nation-wide study.

Study Overview

Status

Completed

Conditions

Detailed Description

Context: Listeriosis is a foodborne infection responsible for severe disease. Surveillance of human listeriosis in France is based on both mandatory reporting of cases and voluntary submission of L. monocytogenes strains to the National Reference Center for Listeria (NRC) since 1999. The exhaustiveness of this reporting estimated by capture-recapture is of at least 87%. A recent and consistent increase of sporadic and cluster-associated systemic listeriosis cases has been reported in Europe since several years (since 2006 in France), but remains poorly understood in the absence of any new environmental risk factor(s). A total of 322 cases have been reported in 2009 in France. Three main clinical forms are identified: septicemia, central nervous system and maternal-fetal infection. They have been characterized only through retrospective studies and pooling of heterogeneous patients. Such studies do not provide an accurate picture of the disease and fail to identify precise biological / genetic risk factors for the disease. Prognostic factors associated with higher risk of death, of severe neurological impairment or of fetal loss also remain to be determined.

Main purpose:

- to study clinical, biological and genetic risk factors for systemic listeriosis and identify determinants of listeriosis-associated mortality in the setting of a large prospective nation-wide study

Secondary purposes:

  • to determine the clinical/biological and radiological presentation of listeriosis
  • to describe and further study current therapeutic practices in the 3 forms of the disease (namely, septicaemic, neurologic and maternal-fetal)
  • to identify inherited risk factors for listeriosis

Ancillary studies:

- to evaluate serologic/PCR diagnostic tools

Study design:

National prospective multicenter study with nested case control study. Clinical, biological and radiological data are collected. Additionally a questionnaire focusing on dietary habits is proposed. A bank of biological samples is performed. For each patient, 25ml of heparinized blood / and 2ml of serum are collected per patient

Study Type

Observational

Enrollment (Actual)

2132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75015
        • Centre National de Reference et Centre Collaborateur OMS Listeria, Institut Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Case: patient with culture-proven listeriosis (blood CSF, fetal/placental sample, other…).

Controls: patient above the age of 18 years with medical background and clinical features compatible with one of the 3 forms of systemic listeriosis: febrile pregnant women (temp > 38°C), febrile patient with co-morbidity for septicaemic listeriosis, and any febrile symptom leading to empiric amoxicillin prescription.

Description

Inclusion Criteria:

Case:

  • Patient with culture-proven listeriosis (blood, CSF, fetal/placental sample, other…).

Control:

  • Patient above the age of 18 years with medical background and clinical features compatible with one of the 3 forms of systemic listeriosis: febrile pregnant women (temp > 38°C), febrile patient with co-morbidity for septicaemic listeriosis, and any febrile symptom leading to empiric amoxicillin prescription.
  • For feasibility reasons, controls are included in Paris (France) emergency wards.

Exclusion Criteria:

Case:

  • Patient who would refuse to sign informed consent agreement

Control:

  • Patient who would refuse to sign informed consent agreement, or whose samples would evidence L. monocytogenes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case
Patient with culture-proven listeriosis
Control
Patient above the age of 18 years with medical background and clinical features compatible with one of the 3 forms of systemic listeriosis: febrile pregnant women (temp > 38°C), febrile patient with co-morbidity for septicaemic listeriosis, and any febrile symptom leading to empiric amoxicillin prescription.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical, biological and genetic risk factors for systemic listeriosis
Time Frame: At Day 1 (case and control)
Clinical, biological and genetic risk factors for systemic listeriosis and identify determinants of listeriosis-associated mortality in the setting of a large prospective nation-wide study
At Day 1 (case and control)
Clinical, biological and genetic risk factors for systemic listeriosis
Time Frame: At Day 90 (case)
Clinical, biological and genetic risk factors for systemic listeriosis and identify determinants of listeriosis-associated mortality in the setting of a large prospective nation-wide study
At Day 90 (case)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical/biological and radiological presentation of listeriosis
Time Frame: At Day 1 and Day 90 (case), at Day 1 (control)
To determine the clinical/biological and radiological presentation of listeriosis
At Day 1 and Day 90 (case), at Day 1 (control)
Current therapeutic practices
Time Frame: At Day 1 and Day 90 (case), at Day 1 (control)
to describe and further study current therapeutic practices in the 3 forms of the disease (septicaemic, neurological and maternal-fetal)
At Day 1 and Day 90 (case), at Day 1 (control)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut Pasteur
French National sanitory

Investigators

  • Principal Investigator: Caroline Charlier, MD, PhD, Institut Pasteur
  • Study Director: Lecuit Marc, MD, PhD, Institut Pasteur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2009

Primary Completion (Actual)

April 5, 2013

Study Completion (Actual)

July 20, 2023

Study Registration Dates

First Submitted

January 3, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimated)

January 30, 2012

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM 09068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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