Molecular Epidemiology of Enteroviruses Detected at the Virology Laboratory of Brest University Hospital During the Period 2018-2024: Retrospective Analysis of an Atypical Meningitis Epidemic in 2024 (BrEcho9Men) (BrEcho9Men)

April 3, 2025 updated by: University Hospital, Brest

Molecular Epidemiology of Enteroviruses Detected at the Virology Laboratory of Brest University Hospital During the Period 2018-2024: Retrospective Analysis of an Atypical Meningitis Epidemic in 2024

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29200
        • CHU Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phylogenetic analysis of Echo-9 strains detected between 2018 and 2024
Time Frame: January 1, 2018 to December 31, 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Temporal distribution of enterovirus infections documented at CHU de Brest
Time Frame: January 1, 2018 to December 31, 2024
Weekly quantification of enterovirus-positive cases (by RT-PCR) detected at CHU de Brest from 2018 to 2024. Comparison with national surveillance data from the French National Reference Center to detect atypical epidemic peaks, with a focus on 2024.
January 1, 2018 to December 31, 2024
Clinical characteristics of enterovirus-positive CSF cases
Time Frame: January 1, 2018 to December 31, 2024
Among patients with cerebrospinal fluid samples positive for enterovirus between 2018 and 2024, clinical features will be described, including headache intensity, clinical severity, infection site (CSF, throat, stool, nasopharyngeal samples), and use of morphine. Subgroup comparisons may be conducted according to enterovirus genotype and year of infection, depending on the results of molecular typing.
January 1, 2018 to December 31, 2024
Biological characteristics of enterovirus-positive CSF samples
Time Frame: January 1, 2018 to December 31, 2024
Among patients with cerebrospinal fluid samples positive for enterovirus between 2018 and 2024, biological parameters from positive samples will be described. For cerebrospinal fluid samples, variables include white blood cell count with differential, protein level, and the cerebrospinal fluid to blood glucose ratio. The presence or absence of additional positive samples (throat, stool, nasopharyngeal swabs) will also be documented.
January 1, 2018 to December 31, 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 29BRC25.0054 - BrEcho9Men

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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