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NCT02924220: MONALISAGENBIO
Genetic Susceptibility and Biomarkers in Listeriosis
trial in Listeriosis in 1,080 participants. Completed in 30 September 2021.
30 September 2021
Quick facts
| Lead sponsor | Institut Pasteur |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,080 |
| Start date | 16 February 2017 |
| Primary completion | 30 September 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across France |
Conditions studied
- Listeriosis — all drugs for Listeriosis →
Sponsor
Institut Pasteur — full company profile →
Who can join
Eligibility, any sex, with Listeriosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02924220
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Listeriosis
Currently open trials in the same condition.
- NCT03357536 — Genetic Susceptibility to Listeriosis · NA · recruiting
Other Institut Pasteur trials
Trials by the same sponsor.
- NCT07205913 — Gut Microbiota, Diet-INDuced Obesity and Type 2 Diabetes in New Caledonia - MIND · not yet recruiting
- NCT06945822 — Characterizing the Host Response to Leptospirosis for Better Diagnosis and Prognosis - NIHFI · NA · not yet recruiting
- NCT05821478 — Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients · Phase 3 · recruiting
- NCT06769815 — Host Immunity, Plasmodium and Pathogens Co-Infections · NA · not yet recruiting
- NCT06718127 — Description of the Immune Response to Yellow Fever Vaccination · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02924220 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut Pasteur
- Last refreshed: 18 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02924220.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing