Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2132 participants
OBSERVATIONAL
2009-11-01
2023-07-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prevalence of Digestive Carriage of Integrons
NCT01985217
Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteria in Preterm Premature Rupture of Membranes : A French Multicenter Cohort Study
NCT07200999
Prognostic Factors of Escherichia Coli Bloodstream Infections: Severity Score and Therapeutic Implications
NCT02890901
Prevalence and Risk Factors for Coxiella Burnetii Seropositivity (Q Fever) Among Adults in Western France
NCT03334019
Prevalence of Clinical Strains of Enterobacteria With Reduced Susceptibility to Carbapenems in the North-West Region of France
NCT02799225
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Case
Patient with culture-proven listeriosis
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut Pasteur
INDUSTRY
French National sanitory
UNKNOWN
URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Caroline Charlier, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Pasteur
Lecuit Marc, MD, PhD
Role: STUDY_DIRECTOR
Institut Pasteur
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre National de Reference et Centre Collaborateur OMS Listeria, Institut Pasteur
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Charlier C, Kermorvant-Duchemin E, Perrodeau E, Moura A, Maury MM, Bracq-Dieye H, Thouvenot P, Vales G, Leclercq A, Ravaud P, Lecuit M. Neonatal Listeriosis Presentation and Outcome: A Prospective Study of 189 Cases. Clin Infect Dis. 2022 Jan 7;74(1):8-16. doi: 10.1093/cid/ciab337.
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. doi: 10.1097/00005792-199809000-00002.
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. doi: 10.1097/00005792-200207000-00002. No abstract available.
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. doi: 10.1126/science.1059852.
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.
Charlier C, Perrodeau E, 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.
Charlier C, Barrault Z, Rousseau J, Kermorvant-Duchemin E, Meyzer C, Semeraro M, Fall M, Coulpier G, Leclercq A, Charles MA, Ancel PY, Lecuit M. Long-term neurological and neurodevelopmental outcome of neonatal listeriosis in France: a prospective, matched, observational cohort study. Lancet Child Adolesc Health. 2023 Dec;7(12):875-885. doi: 10.1016/S2352-4642(23)00195-5. Epub 2023 Oct 20.
Charlier C, Poiree S, Delavaud C, Khoury G, Richaud C, Leclercq A, Helenon O, Lecuit M; MONALISA Study Group. Imaging of Human Neurolisteriosis: A Prospective Study of 71 Cases. Clin Infect Dis. 2018 Oct 15;67(9):1419-1426. doi: 10.1093/cid/ciy449.
Charlier C, Perrodeau E, Levallois C, Cachina T, Dommergues M, Salomon LJ, Azria E, Goffinet F, Ravaud P, Lecuit M. Causes of fever in pregnant women with acute undifferentiated fever: a prospective multicentric study. Eur J Clin Microbiol Infect Dis. 2020 May;39(5):999-1002. doi: 10.1007/s10096-019-03809-3. Epub 2020 Jan 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AOM 09068
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.