Skip to content

National Study on Listeriosis and Listeria

Multicentric Observational NAtional Study on LISteriosis and ListeriA

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01520597
Acronym
MONALISA
Enrollment
2132
Registered
2012-01-30
Start date
2009-11-01
Completion date
2023-07-20
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Infections, Infectious, Listeriosis, Pregnancy Complications, Sepsis; Listeria Monocytogenes, Septicemia

Keywords

Multicentric, National, Prospective on, Listeriosis, Listeria

Brief summary

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.

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

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
Institut Pasteur
CollaboratorINDUSTRY
French National sanitory
CollaboratorUNKNOWN
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical, biological and genetic risk factors for systemic listeriosisAt 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

Secondary

MeasureTime frameDescription
Clinical/biological and radiological presentation of listeriosisAt Day 1 and Day 90 (case), at Day 1 (control)To determine the clinical/biological and radiological presentation of listeriosis
Current therapeutic practicesAt 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)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORCaroline Charlier, MD, PhD

Institut Pasteur

STUDY_DIRECTORLecuit Marc, MD, PhD

Institut Pasteur

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026