Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07186881

Evolving Diagnostic Approaches to Undocumented Lymphocytic Meningitis and Meningoencephalitis

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recommendation from the infectious diseases team

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Effect of Changes in Diagnostic Protocols for Unexplained Lymphocytic Meningitis and Meningoencephalitis : A Retrospective Single-centre Study

Acronym: CHAN-MEE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.