Enterovirus InfectionsBrEcho9MenNCT06922474
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)
An observational study of Enterovirus Infections and Meningitis, Viral, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 100 years
- Conditions the study is for
- Enterovirus Infections, Meningitis, Viral, Meningitis Enterovirus
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients under legal protection (guardianship, curatorship, etc.)
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Echovirus 9, Enterovirus, Viral meningitis, Molecular epidemiology, Phylogenetic analysis, RT-PCR, Retrospective study, Surveillance, France, outbreak, Emerging variant, France epidemiology
- Medical subject headings
- Enterovirus Infections, Meningitis, Viral
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 1, 2018 to December 31, 2024
Secondary outcomes (3)
Temporal distribution of enterovirus infections documented at CHU de Brest
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.
Measured: January 1, 2018 to December 31, 2024
Clinical characteristics of enterovirus-positive CSF cases
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.
Measured: January 1, 2018 to December 31, 2024
Biological characteristics of enterovirus-positive CSF samples
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.
Measured: January 1, 2018 to December 31, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Mar 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterovirus InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922474
- Sponsor's protocol ID
- 29BRC25.0054 - BrEcho9Men
- Acronym
- BrEcho9Men
- Status last verified
- Mar 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06922474
- Acronym / sponsor ID
- BrEcho9Men / 29BRC25.0054 - BrEcho9Men
- Keywords
- Echovirus 9, Enterovirus, Viral meningitis, Molecular epidemiology, Phylogenetic analysis, RT-PCR, Retrospective study, Surveillance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 days to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients under legal protection (guardianship, curatorship, etc.)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Temporal distribution of enterovirus infections documented at CHU de Brest
Time frame: January 1, 2018 to December 31, 2024
Clinical characteristics of enterovirus-positive CSF cases
Time frame: January 1, 2018 to December 31, 2024
Biological characteristics of enterovirus-positive CSF samples
Time frame: January 1, 2018 to December 31, 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterovirus Infections and Meningitis, Viral, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phylogenetic analysis of Echo-9 strains detected between 2018 and 2024 (time frame: January 1, 2018 to December 31, 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.