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

January 13, 2026 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bologna
      • Bologna, Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include cases from various centers in the Bologna metropolitan area, involving adult and pediatric patients, including newborns, whose CSF was analyzed at the Microbiology Unit of the IRCCS AOUBO, Policlinico di Sant'Orsola, between January 1, 2014, and December 31, 2024.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
immunocompetent adults
immunocompetent pediatric
adult and paediatric immunosuppressed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Positivity to different etiological agents (CMV, HSV-1, HSV-2, HHV-6, VZV, EBV, EV) by patient type (pediatric, adult, immunocompetent, immunocompromised)
Time Frame: 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.
at enrolment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical course of the patient with episode of viral meningitis, taking into account the type of patient (pediatric, adult, immunocompetent, immunocompromised) and the pathogen
Time Frame: at enrolment
For 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.
at enrolment
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.
Time Frame: at enrolment
For 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.
at enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Liliana Gabrielli, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Study Chair: Giulio Virgili, MD, AUSL di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCR-VIR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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