Pregnancy Complications Clinical Trial
— MONALISAOfficial title:
Multicentric Observational NAtional Study on LISteriosis and ListeriA
NCT number | NCT01520597 |
Other study ID # | AOM 09068 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2009 |
Est. completion date | July 20, 2023 |
Verified date | January 2024 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2132 |
Est. completion date | July 20, 2023 |
Est. primary completion date | April 5, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre National de Reference et Centre Collaborateur OMS Listeria, Institut Pasteur | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | French National sanitory, Institut Pasteur |
France,
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, matche — View Citation
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 — View Citation
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. — View Citation
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 an — View Citation
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. 202 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | Clinical/biological and radiological presentation of listeriosis | To determine the clinical/biological and radiological presentation of listeriosis | At Day 1 and Day 90 (case), at Day 1 (control) | |
Secondary | Current therapeutic practices | to describe and further study current therapeutic practices in the 3 forms of the disease (septicaemic, neurological and maternal-fetal) | At Day 1 and Day 90 (case), at Day 1 (control) |
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