National Study on Listeriosis and Listeria (MONALISA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Institut Pasteur
French National sanitory
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01520597
First received: January 3, 2012
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Multicentric Observational NAtional Study on LISteriosis and ListeriA

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Clinical, biological and genetic risk factors for systemic listeriosis [ Time Frame: At Day 1 (case and control) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1200
Study Start Date: November 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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)

Ancillary studies:

- to evaluate serologic/PCR diagnostic tools and identify inherited risk factors for listeriosis

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

  Eligibility

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Caroline, 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

Additional Information:
Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01520597     History of Changes
Other Study ID Numbers: AOM 09068
Study First Received: January 3, 2012
Last Updated: July 26, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Multicentric
National
Prospective on
Listeriosis
Listeria

Additional relevant MeSH terms:
Central Nervous System Infections
Communicable Diseases
Infection
Listeriosis
Pregnancy Complications
Sepsis
Toxemia
Central Nervous System Diseases
Nervous System Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014