Meningitis Enterovirus Clinical Trial
— Bledi-CytokineOfficial title:
Study of the Inflammatory Response to Enterovirus Meningitis in Newborns, Infants and Children, as Assessed by Cytokine Levels in Blood and Cerebrospinal Fluid. Case-control Comparison Using an Existing Cohort.
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.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | June 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 16 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: 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). |
Country | Name | City | State |
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France | University Hospital, Clermont Ferrand | Clermont-Ferrand | Aura |
Lead Sponsor | Collaborator |
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University Hospital, Clermont-Ferrand | Laboratory of virology, National Enterovirus and parechovirus Reference Center, University Hospital of Clermont-Ferrand |
France,
Lafolie J, Labbé 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Expression of cytokine in blood | Level of cytokine in blood | Day 1 | |
Primary | Expression of cytokine in cerebrospinal fluid | Level of cytokine in cerebrospinal fluid | Day 1 |