NCT07186881

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Aug 2022Aug 2026

Study Start

First participant enrolled

August 15, 2022

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

September 16, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

Tick bite encephalitisencephalitismeningitidisoutcomesdiagnosis

Outcome Measures

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.

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

Study Arms (2)

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

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.

Period after the change of practice

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Nancy, Brabois Hospital

Vandœuvre-lès-Nancy, Lorraine, 54511, France

Location

MeSH Terms

Conditions

Tick BitesEncephalitisMeningitisEncephalitis, ViralDisease

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisVirus DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor (MD PhD)

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 22, 2025

Study Start

August 15, 2022

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations