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Enrolling by invitationNCT07186881CHAN-MEEUpdated Sep 22, 2025

Evolving Diagnostic Approaches to Undocumented Lymphocytic Meningitis and Meningoencephalitis

An observational study in Tick Bites, Encephalitis and Meningitis, sponsored by Central Hospital, Nancy, France. Enrolling by invitation at 1 site in France. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
200
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Tick Bites
  • Encephalitis
  • Meningitis
  • Viral Encephalitis

Keywords

  • Tick bite encephalitis
  • encephalitis
  • meningitidis
  • outcomes
  • diagnosis
03

In context

Encephalitis

125 studies on the registry are indexed under Encephalitis; 33 are open to participants now.

This study's planned enrollment of 200 is below the median of 300 across 54 observational studies indexed under Encephalitis.

Browse Encephalitis studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Recommendation from the infectious diseases team

Interventions

  • OtherRecommendation from the infectious diseases team

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: This study compares data from the pre-intervention period (2022-2024) with that from the post-intervention period (2024-2026).

07

Study locations

1 site
  • University Hospital of Nancy, Brabois Hospital
    Vandœuvre-lès-Nancy, Lorraine 54511, France
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07186881
Responsible party
LEFEVRE Benjamin (Doctor (MD PhD), Central Hospital, Nancy, France) — Principal investigator
First posted
Sep 22, 2025
Start date
Aug 15, 2022
Primary completion
Aug 15, 2026 (estimated)
Completion
Aug 15, 2026 (estimated)
Last update
Sep 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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