- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06922474
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
Active, not recruiting
Study Type
Observational
Enrollment (Estimated)
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
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Brest, France, 29200
- CHU Brest
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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
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
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
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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.
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January 1, 2018 to December 31, 2024
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Secondary Outcome Measures
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
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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.
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January 1, 2018 to December 31, 2024
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Clinical characteristics of enterovirus-positive CSF cases
Time Frame: January 1, 2018 to December 31, 2024
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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.
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January 1, 2018 to December 31, 2024
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Biological characteristics of enterovirus-positive CSF samples
Time Frame: January 1, 2018 to December 31, 2024
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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.
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January 1, 2018 to December 31, 2024
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 1, 2025
Primary Completion (Estimated)
October 31, 2025
Study Completion (Estimated)
October 31, 2025
Study Registration Dates
First Submitted
April 3, 2025
First Submitted That Met QC Criteria
April 3, 2025
First Posted (Actual)
April 10, 2025
Study Record Updates
Last Update Posted (Actual)
April 10, 2025
Last Update Submitted That Met QC Criteria
April 3, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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