InfectionNCT07358117
Viral Infections of the Central Nervous System: Diagnosis and Clinical Outcome
An observational study of Infection and Virus Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection, Virus Disease, CNS Infection
- How many people
- 4,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2025to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
About this study
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.
Read the 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.
- Conditions
- Infection, Virus Disease, CNS Infection
- Medical subject headings
- Infections, Virus Diseases, Central Nervous System Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| immunocompetent adults | Not described | |
| immunocompetent pediatric | Not described | |
| adult and paediatric immunosuppressed | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
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.
Measured: at enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2025
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liliana Gabrielli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di BolognaGiulio Virgili, MD, Study chair, AUSL di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358117
- Sponsor's protocol ID
- LCR-VIR
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34979025Handley 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.
PubMed 34352616Gabrielli 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.
PubMed 36985122Autore 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.
PubMed 34572214Al-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.
PubMed 35783317
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Infections of the Central Nervous System: Diagnosis and Clinical Outcome
- ClinicalTrials.gov ID
- NCT07358117
- Acronym / sponsor ID
- LCR-VIR
- Conditions
- Infection, Virus Disease, CNS Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| immunocompetent adults | – | – |
| immunocompetent pediatric | – | – |
| adult and paediatric immunosuppressed | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 34979025Jakobsen 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.
- Background: PubMed 34352616Handley 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.
- Background: PubMed 36985122Gabrielli 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.
- Background: PubMed 34572214Autore 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.
- Background: PubMed 35783317Al-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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liliana Gabrielli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Giulio Virgili, MD study chair
AUSL di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Virus Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07358117, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.