NCT06922474

Brief Summary

This study is being done to learn more about enterovirus infections detected in the cerebrospinal fluid of patients at CHU de Brest. Researchers will analyze medical records and laboratory data collected between 2018 and 2024. They will look at how these infections present in patients, and whether a specific virus type, called Echo-9, may be associated with different clinical features or represent an emerging variant.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

April 10, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

April 3, 2025

Last Update Submit

April 3, 2025

Conditions

Keywords

Echovirus 9EnterovirusViral meningitisMolecular epidemiologyPhylogenetic analysisRT-PCRRetrospective studySurveillanceFranceoutbreakEmerging variantFrance epidemiology

Outcome Measures

Primary Outcomes (1)

  • Phylogenetic analysis of Echo-9 strains detected between 2018 and 2024

    Molecular characterization and phylogenetic comparison of Echo-9 strains detected at CHU de Brest and throughout France between January 1, 2018 and December 31, 2024, to identify a possible emerging variant.

    January 1, 2018 to December 31, 2024

Secondary Outcomes (3)

  • Temporal distribution of enterovirus infections documented at CHU de Brest

    January 1, 2018 to December 31, 2024

  • Clinical characteristics of enterovirus-positive CSF cases

    January 1, 2018 to December 31, 2024

  • Biological characteristics of enterovirus-positive CSF samples

    January 1, 2018 to December 31, 2024

Eligibility Criteria

Age0 Days - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a cerebrospinal fluid sample positive for enterovirus by RT-PCR performed at the virology laboratory of CHU de Brest between 2018 and 2024. This includes patients managed at CHU de Brest as well as at partner hospitals in Finistère (France) whose samples were processed centrally.

You may qualify if:

  • Cerebrospinal fluid (CSF) sample positive for enterovirus by RT-PCR between January 1, 2018 and December 31, 2024 , performed at the virology laboratory of CHU de Brest.
  • No documented opposition to the use of medical data for research purposes.

You may not qualify if:

  • Patients under legal protection (guardianship, curatorship, etc.)
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Brest

Brest, 29200, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Clinical specimens tested positive for enteroviruses by RT-PCR will be retained. These include cerebrospinal fluid (CSF), throat swabs, stool samples, and nasopharyngeal swabs collected as part of routine care.

MeSH Terms

Conditions

Enterovirus InfectionsMeningitis, Viral

Condition Hierarchy (Ancestors)

Picornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsCentral Nervous System Viral DiseasesCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 10, 2025

Study Start

March 1, 2025

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

April 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations