Characterization of Cytokines Expression During Enterovirus Meningitis in Paediatric Populations.

NCT04711876 | Unknown

• 1 other identifier: 2020 ARCHIMBAUD Bledi-Cytokine
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Enteroviruses (EV) are the most frequent cause of acute meningitis in the paediatric population. Detection of enterovirus in cerebrospinal fluid (CSF) specimens by Polymerase Chain Reaction (PCR) is the gold standard diagnostic test. Recently, our laboratory published the BLEDI study which highlighted the interest of detecting EV in the blood of the paediatric population : (i) EV was found in more than a quarter of cases in the blood of infants admitted to hospital with isolated fever and (ii) detection of EV was more frequent in the blood than in CSF in neonates and infants with isolated fever, sepsis or meningitis. However, the pathophysiology of EV infections is poorly understood and little work has been done on the inflammatory response to these infections. In EV meningitis, the inflammatory response has been studied primarily in children infected with enterovirus A71 (EV-A71). Indeed, in these children, inappropriate cytokine secretion (cytokine storm) leads to severe neurological and cardiopulmonary damage, which can progress to death. The study of the inflammatory response during meningitis due to other types of EV remains poorly The objective of BLEDI-CYTOKINES (ancillary study of the BLEDI study) is to study the inflammatory response during EV meningitis in neonates, infants and children, as assessed by cytokine levels in blood and cerebrospinal fluid, by comparing case-controls from an existing cohort.

Conditions

Meningitis Enterovirus

Keywords

Enterovirus infection; Cytokine expression; Paediatric population; Blood; Cerebrospinal fluid; Inflammatory; Meningitis viral

Outcome Measures

Primary Outcomes (2)

• Expression of cytokine in blood

  Level of cytokine in blood

  Day 1

• Expression of cytokine in cerebrospinal fluid

  Level of cytokine in cerebrospinal fluid

  Day 1

Study Arms (2)

Test group with enterovirus meningitis

Level of Cytokine in blood and CSF for Patient with RT-PCR-EV +

Biological: Cytokine level in blood and CSF

Control group with no enterovirus meningitis

Level of Cytokine in blood and CSF for Patient with RT-PCR-EV -

Biological: Cytokine level in blood and CSF

Interventions

Cytokine level in blood and CSF BIOLOGICAL

Measure of cytokine level

Control group with no enterovirus meningitis; Test group with enterovirus meningitis

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Paediatric patient with suspicion of meningitis

You may qualify if:

• Patients with proven enterovirus meningitis (RT- PCR EV positive)
• Control patients admitted for suspected meningitis infection but for whom the bacteriological (LCS culture/ blood culture negative) and virological diagnosis (testing for enteroviruses (RT-PCR negative) and parechoviruses (viruses responsible for symptoms similar to those of EVs) is negative

You may not qualify if:

• For patients with EV meningitis, we will exclude:
• patients with co-infection
• haemorrhagic CSF samples
• samples (CSF or blood) for which we do not have access to EV viral load results
• samples (CSF or blood) for which we do not have access to the EV genotyping results
• For patients in the control group (without EV meningitis), we will exclude :
• Samples from patients with an infection (viral or bacterial) in the control group.
• haemorrhagic CSF samples
• CSF samples with pleocytosis (presence of CSF leucocytes).
• Blood samples with high CRP (CRP\>15mg/L).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Laboratory of virology, National Enterovirus and parechovirus Reference Center, University Hospital of Clermont-Ferrand: collaborator

Study Sites (1)

University Hospital, Clermont Ferrand

Clermont-Ferrand, AURA, 63000, France

Location

Related Publications (1)

• Lafolie J, Labbe A, L'Honneur AS, Madhi F, Pereira B, Decobert M, Adam MN, Gouraud F, Faibis F, Arditty F, Marque-Juillet S, Guitteny MA, Lagathu G, Verdan M, Rozenberg F, Mirand A, Peigue-Lafeuille H, Henquell C, Bailly JL, Archimbaud C; Blood Enterovirus Diagnosis Infection (BLEDI) in paediatric population study team. Assessment of blood enterovirus PCR testing in paediatric populations with fever without source, sepsis-like disease, or suspected meningitis: a prospective, multicentre, observational cohort study. Lancet Infect Dis. 2018 Dec;18(12):1385-1396. doi: 10.1016/S1473-3099(18)30479-1. Epub 2018 Oct 30.

  PMID: 30389482 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and CSF taken from paediatric patient during hospitalisation for suspicion of meningitis (Sample taken from 2015 and 2016 according to the BLEDI Study)

MeSH Terms

Conditions

Enterovirus Infections; Meningitis, Viral

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Central Nervous System Viral Diseases; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

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

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: April 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

FR (1)