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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07358117
Enrollment
4000
Registered
2026-01-22
Start date
2025-12-01
Completion date
2027-06-01
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CNS Infection, Infection, Virus Disease

Brief 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.

Detailed description

The objectives are: 1) to verify whether the different categories of patients present a different distribution of etiological agents (Citomegalovirus, Herpes Simplex Virus 1, Herpes Simplex Virus 2, Human Herpesvirus 6, Varicella Zoster Virus, Epstein-Barr Virus, Enterovirus) for CNS infection; 2) to verify whether the course and clinical manifestations of the disease can be associated with the identified etiological agent and the type of patient; 3) to describe the results of instrumental tests (EEC and/or MRI and/or CT) in patients who tested positive for a neurotropic virus responsible for the infection.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Positivity to different etiological agents (CMV, HSV-1, HSV-2, HHV-6, VZV, EBV, EV) by patient type (pediatric, adult, immunocompetent, immunocompromised)at enrolmentFor 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.

Secondary

MeasureTime frameDescription
Clinical course of the patient with episode of viral meningitis, taking into account the type of patient (pediatric, adult, immunocompetent, immunocompromised) and the pathogenat enrolmentFor secondary objectives, only positive cases of viral etiological agent will be considered and, by accessing the data recorded in the patient's medical record, information regarding symptoms, the outcome of the instrumental examination performed, and the course of the individual hospital stay will be retrieved. Post-discharge, only neurological sequelae will be considered at follow-up at \> 6 months, during the follow-up visit with the infectious disease physician.
Distribution of instrumental outcomes of EEC, MRI, CT (normal or non-normal), in the patient with infectious episode, taking into account the patient type (pediatric, adult, immunocompetent, immunocompromised) and the pathogen detected.at enrolmentFor secondary objectives, only positive cases of viral etiological agent will be considered and, by accessing the data recorded in the patient's medical record, information regarding symptoms, the outcome of the instrumental examination performed, and the course of the individual hospital stay will be retrieved. Post-discharge, only neurological sequelae will be considered at follow-up at \> 6 months, during the follow-up visit with the infectious disease physician.

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORLiliana Gabrielli, MD

IRCCS Azienda Ospedaliero-Universitaria di Bologna

STUDY_CHAIRGiulio Virgili, MD

AUSL di Bologna

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026