National Study on Listeriosis and Listeria (MONALISA)
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ClinicalTrials.gov Identifier: NCT01520597 |
Recruitment Status
:
Recruiting
First Posted
: January 30, 2012
Last Update Posted
: August 2, 2016
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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.
Condition or disease |
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Listeriosis Pregnancy Complications Infectious Central Nervous System Infections Septicemia Sepsis; Listeria Monocytogenes |
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 |
Estimated Enrollment : | 1200 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Multicentric Observational NAtional Study on LISteriosis and ListeriA |
Study Start Date : | November 2009 |
Estimated Primary Completion Date : | October 2018 |
Estimated Study Completion Date : | April 2019 |

Group/Cohort |
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Case
Patient with culture-proven listeriosis
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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.
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- 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
- 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
- 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
- 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)
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520597
Contact: Caroline Charlier, MD, PhD | +33(0) 1 42 19 26 63 | caroline.charlier@nck.aphp.fr | |
Contact: Laurence Lecomte, PhD | +33 (0)1 71 19 64 94 | laurence.lecomte@nck.aphp.fr |
France | |
Centre National de Reference et Centre Collaborateur OMS Listeria, Institut Pasteur | Recruiting |
Paris, France, 75015 | |
Contact: Caroline Charlier, MD PhD +33 (0)1 42 19 26 63 caroline.charlier@nck.aphp.fr |
Principal Investigator: | Caroline Charlier, MD, PhD | Institut Pasteur | |
Study Director: | Lecuit Marc, MD, PhD | Institut Pasteur |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01520597 History of Changes |
Other Study ID Numbers: |
AOM 09068 |
First Posted: | January 30, 2012 Key Record Dates |
Last Update Posted: | August 2, 2016 |
Last Verified: | July 2016 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Multicentric National Prospective on Listeriosis Listeria |
Additional relevant MeSH terms:
Pregnancy Complications Central Nervous System Infections Infection Gram-Positive Bacterial Infections Bacterial Infections Sepsis |
Listeriosis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Central Nervous System Diseases Nervous System Diseases |