Clinical Trial: National Study on Listeriosis and Listeria

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Multicentric Observational NAtional Study on LISteriosis and 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 Summary:

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 inher
  Sponsor: Assistance Publique - Hôpitaux de Paris
  

  Current Primary Outcome:

  • 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
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • 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)
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Assistance Publique - Hôpitaux de Paris
  

  Dates:
  Date Received: January 3, 2012
  Date Started: November 2009
  Date Completion: April 2019
  Last Updated: July 31, 2016
  Last Verified: July 2016