Tick BitesCHAN-MEENCT07186881
Evolving Diagnostic Approaches to Undocumented Lymphocytic Meningitis and Meningoencephalitis
An observational study of Tick Bites and Encephalitis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Tick-borne encephalitis (TBE) is a viral infection transmitted by ticks. TBE is the third most common cause of encephalitis in France. Across France, numerous cases of lymphocytic meningitis remain without a definitive diagnosis, notably at the Nancy University Hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tick Bites, Encephalitis, Meningitis
- What is being tested?
- Recommendation from the infectious diseases team
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Aug 2022to 15 Aug 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inclusion Criteria: * Individuals who have received full information regarding the organisation and conduct of the study * Adults or children * Hospitalised in a department of Nancy University Hospital with a diagnosis of lymphocytic meningitis or meningoencephalitis * Cerebrospinal fluid showing more than 5 cells/mm³, with either a negative FilmArray result or no FilmArray performed Exclusion Criteria: * Patients diagnosed with non-lymphocytic meningitis or meningoencephalitis * Patients with documented lymphocytic meningitis or meningoencephalitis of a known cause (excluding TBE) prior to the date the advisory was issued * Patients who have expressed opposition to the use of their data for this study
Who may be able to join
- Individuals who have received full information regarding the organisation and conduct of the study
- Adults or children
- Hospitalised in a department of Nancy University Hospital with a diagnosis of lymphocytic meningitis or meningoencephalitis
- Cerebrospinal fluid showing more than 5 cells/mm³, with either a negative FilmArray result or no FilmArray performed
Who cannot join
- Patients diagnosed with non-lymphocytic meningitis or meningoencephalitis
- Patients with documented lymphocytic meningitis or meningoencephalitis of a known cause (excluding TBE) prior to the date the advisory was issued
- Patients who have expressed opposition to the use of their data for this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital of Nancy, Brabois Hospital
Vandœuvre-lès-Nancy, Lorraine, 54511
About this study
Official title: Effect of Changes in Diagnostic Protocols for Unexplained Lymphocytic Meningitis and Meningoencephalitis : A Retrospective Single-centre Study
Tick-borne encephalitis (TBE) is a viral infection transmitted by ticks. TBE is the third most common cause of encephalitis in France. Across France, numerous cases of lymphocytic meningitis remain without a definitive diagnosis, notably at the Nancy University Hospital. The objective of this study is to assess the impact of a change in diagnostic practice on the work-up of undocumented lymphocytic meningitis and meningoencephalitis at Nancy University Hospital.
Read the detailed description
Tick-borne encephalitis (TBE) is a viral infection transmitted by ticks. It is an emerging infectious disease and has been notifiable in France since 2021. TBE is the third most common cause of encephalitis in France, following herpes simplex virus and varicella-zoster virus infections (ENCEIF data).
According to initial data collected by Santé publique France, eastern France is the most affected region, with over half of the reported cases occurring in the Rhône-Alpes and Alsace regions. However, this infection remains relatively unfamiliar to many clinicians and is infrequently investigated during routine diagnostic procedures.
Across France, numerous cases of lymphocytic meningitis remain without a definitive diagnosis, notably at the Nancy University Hospital, where approximately 150 such cases are recorded annually. It is plausible that a proportion of these cases are secondary to TBE infection.
The hypothesis underlying this study is based on these observations. Diagnostic practices at the Nancy University Hospital are currently evolving. The infectious diseases team is actively working to increase clinicians' awareness of TBE, encouraging them to consider this diagnosis when presented with compatible clinical scenarios. Specifically, in cases suggestive of TBE, the infectious diseases team now routinely recommends testing for this pathogen.
This change in practice may lead to an increased rate of documented TBE cases and potentially improve patient management.
The primary objective of this study is to assess the impact of this change in diagnostic practice on the work-up of undocumented lymphocytic meningitis and meningoencephalitis at Nancy University Hospital.
- Conditions
- Tick Bites, Encephalitis, Meningitis, Viral Encephalitis
- Being tested
- Recommendation from the infectious diseases team
- Keywords
- Tick bite encephalitis, encephalitis, meningitidis, outcomes, diagnosis
- Medical subject headings
- Tick Bites, Encephalitis, Meningitis, Encephalitis, Viral, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommendation from the infectious diseases teamOther
No commercial product was evaluated in this study. We are assessing the benefits and consequences of a change in clinical practice implemented at the hospital level. At our institution, it is now recommended that TBE serology be performed in all cases of undocumented meningitis or meningoencephalitis.
The infectious diseases team at our hospital simply advises the clinicians responsible for patient care to perform this test.
| Study group | Role | What they receive |
|---|---|---|
| Period before the change of practice | We are examining a change in clinical practice within our institution. Prior to this change, testing for tick-borne encephalitis (TBE) was not routinely performed in cases of meningitis and meningoencephalitis. Following the implementation of the new protocol, our infectious diseases team now recommends that all clinicians managing patients with compatible clinical presentations conduct TBE serology. The patient cohort described here corresponds to the period preceding this change in practice. | |
| Period after the change of practice | We are examining a change in clinical practice within our institution. Prior to this change, testing for tick-borne encephalitis (TBE) was not routinely performed in cases of meningitis and meningoencephalitis. Following the implementation of the new protocol, our infectious diseases team now recommends that all clinicians managing patients with compatible clinical presentations conduct TBE serology.
The patient cohort described here corresponds to the period following this change in practice. Receives: Other: Recommendation from the infectious diseases team |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBE diagnosis
To measure the impact of revised diagnostic procedures on TBE detection among cases of unexplained clear-fluid meningitis and meningoencephalitis at Nancy University Hospital.
Measured: This study compares data from the pre-intervention period (2022-2024) with that from the post-intervention period (2024-2026).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start15 Aug 2022
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tick BitesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEFEVRE Benjamin, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186881
- Sponsor's protocol ID
- CHAN-MEE
- Acronym
- CHAN-MEE
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated and analysed during the current study are not publicly available due to restrictions by the French law, but are available from the last author on reasonable request at the following email address: b.lefevre@chru-nancy.fr.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Changes in Diagnostic Protocols for Unexplained Lymphocytic Meningitis and Meningoencephalitis : A Retrospective Single-centre Study
- ClinicalTrials.gov ID
- NCT07186881
- Acronym / sponsor ID
- CHAN-MEE / CHAN-MEE
- Conditions
- Tick Bites, Encephalitis, Meningitis, Viral Encephalitis
- Keywords
- Tick bite encephalitis, encephalitis, meningitidis, outcomes, diagnosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 22 Sep 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.
Tick-borne encephalitis (TBE) is a viral infection transmitted by ticks. TBE is the third most common cause of encephalitis in France. Across France, numerous cases of lymphocytic meningitis remain without a definitive diagnosis, notably at the Nancy University Hospital. The objective of this study is to assess the impact of a change in diagnostic practice on the work-up of undocumented lymphocytic meningitis and meningoencephalitis at Nancy University Hospital.
Detailed description
Tick-borne encephalitis (TBE) is a viral infection transmitted by ticks. It is an emerging infectious disease and has been notifiable in France since 2021. TBE is the third most common cause of encephalitis in France, following herpes simplex virus and varicella-zoster virus infections (ENCEIF data).
According to initial data collected by Santé publique France, eastern France is the most affected region, with over half of the reported cases occurring in the Rhône-Alpes and Alsace regions. However, this infection remains relatively unfamiliar to many clinicians and is infrequently investigated during routine diagnostic procedures.
Across France, numerous cases of lymphocytic meningitis remain without a definitive diagnosis, notably at the Nancy University Hospital, where approximately 150 such cases are recorded annually. It is plausible that a proportion of these cases are secondary to TBE infection.
The hypothesis underlying this study is based on these observations. Diagnostic practices at the Nancy University Hospital are currently evolving. The infectious diseases team is actively working to increase clinicians' awareness of TBE, encouraging them to consider this diagnosis when presented with compatible clinical scenarios. Specifically, in cases suggestive of TBE, the infectious diseases team now routinely recommends testing for this pathogen.
This change in practice may lead to an increased rate of documented TBE cases and potentially improve patient management.
The primary objective of this study is to assess the impact of this change in diagnostic practice on the work-up of undocumented lymphocytic meningitis and meningoencephalitis at Nancy University Hospital.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period before the change of practice | – | –We are examining a change in clinical practice within our institution. Prior to this change, testing for tick-borne encephalitis (TBE) was not routinely performed in cases of meningitis and meningoencephalitis. Following the implementation of the new protocol, our infectious diseases team now recommends that all clinicians managing patients with compatible clinical presentations conduct TBE serology. The patient cohort described here corresponds to the period preceding this change in practice. |
| Period after the change of practice | – | Other: Recommendation from the infectious diseases teamWe are examining a change in clinical practice within our institution. Prior to this change, testing for tick-borne encephalitis (TBE) was not routinely performed in cases of meningitis and meningoencephalitis. Following the implementation of the new protocol, our infectious diseases team now recommends that all clinicians managing patients with compatible clinical presentations conduct TBE serology. The patient cohort described here corresponds to the period following this change in practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion Criteria: * Individuals who have received full information regarding the organisation and conduct of the study * Adults or children * Hospitalised in a department of Nancy University Hospital with a diagnosis of lymphocytic meningitis or meningoencephalitis * Cerebrospinal fluid showing more than 5 cells/mm³, with either a negative FilmArray result or no FilmArray performed Exclusion Criteria: * Patients diagnosed with non-lymphocytic meningitis or meningoencephalitis * Patients with documented lymphocytic meningitis or meningoencephalitis of a known cause (excluding TBE) prior to the date the advisory was issued * Patients who have expressed opposition to the use of their data for this study
Key inclusion criteria (4 listed)
- Individuals who have received full information regarding the organisation and conduct of the study
- Adults or children
- Hospitalised in a department of Nancy University Hospital with a diagnosis of lymphocytic meningitis or meningoencephalitis
- Cerebrospinal fluid showing more than 5 cells/mm³, with either a negative FilmArray result or no FilmArray performed
Key exclusion criteria (3 listed)
- Patients diagnosed with non-lymphocytic meningitis or meningoencephalitis
- Patients with documented lymphocytic meningitis or meningoencephalitis of a known cause (excluding TBE) prior to the date the advisory was issued
- Patients who have expressed opposition to the use of their data for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recommendation from the infectious diseases teamNo commercial product was evaluated in this study. We are assessing the benefits and consequences of a change in clinical practice implemented at the hospital level. At our institution, it is now recommended that TBE serology be performed in all cases of undocumented meningitis or meningoencephalitis. The infectious diseases team at our hospital simply advises the clinicians responsible for patient care to perform this test. | Other | Period after the change of practice |
Primary outcome
TBE diagnosis
Time frame: This study compares data from the pre-intervention period (2022-2024) with that from the post-intervention period (2024-2026).
To measure the impact of revised diagnostic procedures on TBE detection among cases of unexplained clear-fluid meningitis and meningoencephalitis at Nancy University Hospital.
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 22 Sep 2025.
- Individual participant dataSharing planned: Undecided. The datasets generated and analysed during the current study are not publicly available due to restrictions by the French law, but are available from the last author on reasonable request at the following email address: b.lefevre@chru-nancy.fr.
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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.
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 Tick Bites and Encephalitis, run by Central Hospital, Nancy, France 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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 22 Sep 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?
TBE diagnosis (time frame: This study compares data from the pre-intervention period (2022-2024) with that from the post-intervention period (2024-2026).). 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 22 Sep 2025.