Trial record 2 of 3 for:    monalisa

National Study on Listeriosis and Listeria (MONALISA)

This study is currently recruiting participants.
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

January 3, 2012
July 26, 2013
November 2009
September 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01520597 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
National Study on Listeriosis and Listeria
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.

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood sample

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.

  • Listeriosis
  • Pregnancy Complications
  • Infectious
  • Central Nervous System Infections
  • Septicemia
  • Sepsis; Listeria Monocytogenes
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
April 2014
September 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
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
 
NCT01520597
AOM 09068
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
  • Institut Pasteur
  • French National sanitory
Principal Investigator: Caroline Charlier, MD, PhD Institut Pasteur
Study Director: Lecuit Marc, MD, PhD Institut Pasteur
Assistance Publique - Hôpitaux de Paris
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP