Listeriosis Clinical Trial
— MONALISAGENBIOOfficial title:
Genetic Susceptibility and Biomarkers in Listeriosis (MONALISA-GENBIO)
Verified date | October 2021 |
Source | Institut Pasteur |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Listeriosis is a rare, severe foodborne infection caused by the bacterium Listeria monocytogenes (Lm). It manifests as septicemia, central nervous system (CNS) infection and maternal-fetal (MF) infection. Its associated overall mortality is very high, above of 30%. A better knowledge on the factors involved in its occurrence and in clinical manifestations is therefore needed to improve outcome. A number of frequent acquired risk factors for listeriosis have been identified, such as pregnancy, diabetes, cancer, HIV infection, and immunosuppressive therapies. However, no genetic study on host susceptibility to listeriosis in humans has been performed so far, in the absence of prospective collection of patients' samples. Also, listeriosis diagnosis is based on Lm culture from clinical samples. This method lacks sensitivity, and the contribution of biomarkers to listeriosis diagnosis and prognosis has not been evaluated. The Multicentric Observational NAtional Analysis of Listeriosis and Listeria (MONALISA), is the first national case-control prospective study on listeriosis. It is implemented since 2009 and enrolls all culture-proven cases declared to the NRCL: and collects for each patient clinical and biological data and biological samples. Controls with comparable background and presentation are also included. 818 cases have been included (427 S, 252 CNS and 107 MN) over 3.5 years, along with 456 controls. The aim of the study is to identify human genetic susceptibility factors to listeriosis, biomarkers to improve its diagnosis and prognosis (survival or death), and thereby help improve management of patients with listeriosis. Samples from the completed cohort will be analyzed : SNPs genotyping and exam sequencing; biomarkers a identification in serum and plasma of patients and controls by simultaneous multi-analyte and metabolomic profiling.
Status | Completed |
Enrollment | 1080 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - All patients have given their written consent to participate in the MONALISA cohort and for the collection of a blood sample including DNA samples for DNA analyses. Exclusion Criteria: - Patients included in the MONALISA cohort without biological sample available. |
Country | Name | City | State |
---|---|---|---|
France | Institut Pasteur, Unité de Biologie des Infections | Paris |
Lead Sponsor | Collaborator |
---|---|
Institut Pasteur | Icahn School of Medicine at Mount Sinai |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Characterisation of genetic susceptibility markers for infection as a whole and for each form and/or for the severity of infection | Characterisation of genetic susceptibility markers for infection as a whole and for each form and/or for the severity of infection by whole exome sequencing and whole genome genotyping for all MONALISA cases and controls | 3 years | |
Secondary | Biomarkers identification in serum and plasma of patients and controls | Biomarkers identification in serum and plasma of patients and controls by simultaneous multi-analyte and metabolomic profiling:
-Characterisation of a biological signature of listeriosis as a whole and for each form of infection. |
3 years | |
Secondary | Biomarkers identification in serum and plasma of patients and controls | Biomarkers identification in serum and plasma of patients and controls by simultaneous multi-analyte and metabolomic profiling:
-Characterisation of the severity of infection (prognosis): death, fetal loss, neurological persisting impairment. |
3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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Genetic Susceptibility to Listeriosis
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N/A | |
Completed |
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