Evolving Diagnostic Approaches to Undocumented Lymphocytic Meningitis and Meningoencephalitis

NCT ID: NCT07186881

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-15

Study Completion Date

2026-08-15

Brief Summary

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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

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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

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Tick Bites Encephalitis Meningitis Viral Encephalitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

Recommendation from the infectious diseases team

Intervention Type 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.

Interventions

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Recommendation 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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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LEFEVRE Benjamin

Doctor (MD PhD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Nancy, Brabois Hospital

Vandœuvre-lès-Nancy, Lorraine, France

Site Status

Countries

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France

Other Identifiers

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CHAN-MEE

Identifier Type: -

Identifier Source: org_study_id

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