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

NCT07358117 | Active Not Recruiting

• 1 other identifier: LCR-VIR
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Virus Disease; CNS Infection

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Clinical course of the patient with episode of viral meningitis, taking into account the type of patient (pediatric, adult, immunocompetent, immunocompromised) and the pathogen

  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.

  at enrolment

Study Arms (3)

immunocompetent adults

immunocompetent pediatric

adult and paediatric immunosuppressed

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Related Publications (5)

• Jakobsen A, Skov MT, Larsen L, Trier Petersen P, Brandt C, Wiese L, Hansen BR, Luttichau HR, Tetens MM, Helweg-Larsen J, Storgaard M, Nielsen H, Bodilsen J. Herpes Simplex Virus 2 Meningitis in Adults: A Prospective, Nationwide, Population-Based Cohort Study. Clin Infect Dis. 2022 Sep 14;75(5):753-760. doi: 10.1093/cid/ciab1071.

  PMID: 34979025 BACKGROUND

• Handley G, Pankow S, Bard JD, Yee R, Nigo M, Hasbun R. Distinguishing cytomegalovirus meningoencephalitis from other viral central nervous system infections. J Clin Virol. 2021 Sep;142:104936. doi: 10.1016/j.jcv.2021.104936. Epub 2021 Jul 25.

  PMID: 34352616 BACKGROUND

• Gabrielli L, Balboni A, Borgatti EC, Virgili G, Petrisli E, Cantiani A, Pavoni M, Baiesi Pillastrini F, Venturoli S, Piccirilli G, Lazzarotto T. Inherited Chromosomally Integrated Human Herpesvirus 6: Laboratory and Clinical Features. Microorganisms. 2023 Feb 21;11(3):548. doi: 10.3390/microorganisms11030548.

  PMID: 36985122 BACKGROUND

• Autore G, Bernardi L, Perrone S, Esposito S. Update on Viral Infections Involving the Central Nervous System in Pediatric Patients. Children (Basel). 2021 Sep 6;8(9):782. doi: 10.3390/children8090782.

  PMID: 34572214 BACKGROUND

• Al-Qahtani SM, Shati AA, Alqahtani YA, Ali AS. Etiology, Clinical Phenotypes, Epidemiological Correlates, Laboratory Biomarkers and Diagnostic Challenges of Pediatric Viral Meningitis: Descriptive Review. Front Pediatr. 2022 Jun 16;10:923125. doi: 10.3389/fped.2022.923125. eCollection 2022.

  PMID: 35783317 BACKGROUND

Related Links

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MeSH Terms

Conditions

Infections; Virus Diseases; Central Nervous System Infections

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Liliana Gabrielli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

• Giulio Virgili, MD

  AUSL di Bologna

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 22, 2026
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)