National Study on Listeriosis and Listeria (MONALISA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01520597

Recruitment Status : Recruiting

First Posted : January 30, 2012

Last Update Posted : August 2, 2016

See Contacts and Locations

Sponsor:

Collaborators:

Institut Pasteur

French National sanitory

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease
Listeriosis Pregnancy Complications Infectious Central Nervous System Infections Septicemia Sepsis; Listeria Monocytogenes

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 Design


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Listeria Infections

Genetic and Rare Diseases Information Center resources: Listeria Infection

U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

blood sample

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Contacts


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

Locations


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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Institut Pasteur

French National sanitory

Investigators


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

More Information

Publications:

Mylonakis E, Hohmann EL, Calderwood SB. Central nervous system infection with Listeria monocytogenes. 33 years' experience at a general hospital and review of 776 episodes from the literature. Medicine (Baltimore). 1998 Sep;77(5):313-36. Review.

Mylonakis E, Paliou M, Hohmann EL, Calderwood SB, Wing EJ. Listeriosis during pregnancy: a case series and review of 222 cases. Medicine (Baltimore). 2002 Jul;81(4):260-9. Review.

Lecuit M, Vandormael-Pournin S, Lefort J, Huerre M, Gounon P, Dupuy C, Babinet C, Cossart P. A transgenic model for listeriosis: role of internalin in crossing the intestinal barrier. Science. 2001 Jun 1;292(5522):1722-5.

Disson O, Grayo S, Huillet E, Nikitas G, Langa-Vives F, Dussurget O, Ragon M, Le Monnier A, Babinet C, Cossart P, Lecuit M. Conjugated action of two species-specific invasion proteins for fetoplacental listeriosis. Nature. 2008 Oct 23;455(7216):1114-8. doi: 10.1038/nature07303. Epub 2008 Sep 17.

Charlier C, Leclercq A, Cazenave B, Desplaces N, Travier L, Cantinelli T, Lortholary O, Goulet V, Le Monnier A, Lecuit M; L monocytogenes Joint and Bone Infections Study Group. Listeria monocytogenes-associated joint and bone infections: a study of 43 consecutive cases. Clin Infect Dis. 2012 Jan 15;54(2):240-8. doi: 10.1093/cid/cir803. Epub 2011 Nov 18.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Charlier C, Perrodeau É, Leclercq A, Cazenave B, Pilmis B, Henry B, Lopes A, Maury MM, Moura A, Goffinet F, Dieye HB, Thouvenot P, Ungeheuer MN, Tourdjman M, Goulet V, de Valk H, Lortholary O, Ravaud P, Lecuit M; MONALISA study group. Clinical features and prognostic factors of listeriosis: the MONALISA national prospective cohort study. Lancet Infect Dis. 2017 May;17(5):510-519. doi: 10.1016/S1473-3099(16)30521-7. Epub 2017 Jan 28.


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

To Top