National Study on Listeriosis and Listeria

NCT01520597 | Completed

• 2 other identifiers: NI08004AOM 09068
• Study Type: observational
• Target: 2,132
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Multicentric; National; Prospective on; Listeriosis; Listeria

Outcome Measures

Primary Outcomes (2)

• Clinical, biological and genetic risk factors for systemic listeriosis

  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

  At Day 1 (case and control)

• Clinical, biological and genetic risk factors for systemic listeriosis

  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

  At Day 90 (case)

Secondary Outcomes (2)

• Clinical/biological and radiological presentation of listeriosis

  At Day 1 and Day 90 (case), at Day 1 (control)

• Current therapeutic practices

  At Day 1 and Day 90 (case), at Day 1 (control)

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pasteur: collaborator
• French National sanitory: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre National de Reference et Centre Collaborateur OMS Listeria, Institut Pasteur

Paris, 75015, France

Location

Related Publications (10)

• 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.

  PMID: 9772921 BACKGROUND

• 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.

  PMID: 12169881 BACKGROUND

• 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.

  PMID: 11387478 BACKGROUND

• 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.

  PMID: 18806773 BACKGROUND

• 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.

  PMID: 22100574 BACKGROUND

• 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.

  PMID: 28139432 RESULT

• 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.

  PMID: 37871603 RESULT

• 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.

  PMID: 29796652 RESULT

• 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.

  PMID: 33876229 RESULT

• 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.

  PMID: 31955353 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Listeriosis; Pregnancy Complications; Communicable Diseases; Central Nervous System Infections; Sepsis

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Nervous System Diseases; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Caroline Charlier, MD, PhD

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

• Lecuit Marc, MD, PhD

  Institut Pasteur

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 30, 2012
• Study Start: November 1, 2009
• Primary Completion: April 5, 2013
• Study Completion: July 20, 2023
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (1)