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Active, not recruiting Observational

Viral Infections of the Central Nervous System: Diagnosis and Clinical Outcome

NCT07358117 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-12-01
Last updated
2026-01-22

Condition(s) studied

InfectionVirus DiseaseCNS Infection

Study summary

Central Nervous System (CNS) infections are caused by bacteria, viruses, fungi, helminths, with several clinical aspects. Studies in the literature generally focus on a single patient type, and no experiences have been reported in which immunosuppressed and immunocompetent adult and pediatric patients were simultaneously examined. Our study will include all possible patient types (immunocompetent adults, immunocompetent pediatric patients, and subjects immunosuppressed by co-softness), to try to more precisely define the clinical and population characteristics of patients who have had an episode of CNS viral infection. These indications may be useful in the future to more specifically guide diagnostic investigations on patients considered at risk.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients whose CSF was analyzed for HSV-1, HSV-2, VZV, EV, EBV, CMV and HHV-6 between 01/01/2014 and 31/12/2024. * Obtaining informed consent. Exclusion Criteria: \- None

Primary outcome measure(s)

  • Positivity to different etiological agents (CMV, HSV-1, HSV-2, HHV-6, VZV, EBV, EV) by patient type (pediatric, adult, immunocompetent, immunocompromised) — at enrolment
    For the primary objective, all required molecular investigations of LCRs collected from patients with suspected viral meningitis will be selected from the management software used at the Virology Laboratory between January 1, 2014, and December 31, 2024. Infectious episodes will be identified in relation to the positivity of the viral etiological agent, considering the result (positive or negative) obtained at the time of diagnosis, without having the need to re-examine the sample. An infectious episode is defined as a hospital admission event with a clinical picture of presumed meningitis of viral origin and consequent microbiological confirmation. Therefore, in case of multiple molecular investigations on the same patient during a single hospitalization, it will be considered as the only infectious event. On the other hand, in the event of multiple hospitalizations per single patient with suspected viral meningitis, they will be considered as different infectious episodes.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07358117 on ClinicalTrials.gov ↗ ← All trials in Italy