NCT07364539

Brief Summary

Central Nervous System (CNS) infections are considered rare conditions but at the same time, they are emergencies whose diagnosis and treatment are time-dependent. They include several clinical syndromes, including meningitis, encephalitis, brain abscesses, and post-surgical meningitis. The classic triad of symptoms includes fever, altered mental status, and neck stiffness, but other common manifestations include nausea and vomiting, cranial nerve dysfunction, skin rash, and seizures. Due to the potentially life-threatening effects on patients, these clinical conditions cannot be underestimated. The CNS includes the brain and spinal cord, surrounded and protected by the meninges and cerebrospinal fluid (CSF). Within the CNS are numerous nuclei responsible for vital functions, as well as more complex intellectual activities.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Mar 2022Jan 2030

Study Start

First participant enrolled

March 4, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2022

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

January 23, 2026

Status Verified

September 1, 2025

Enrollment Period

1 day

First QC Date

December 19, 2025

Last Update Submit

January 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • To evaluate the outcome in terms of mortality at discharge in patients with CNS infections.

    From January 2012

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In the nine years since 2012, we have identified 260 patients with positive CSF tests. We assume that over the next 10 years we will register the same number of patients, for a total of 520 patients. With this sample size, the precision of the mortality estimate over the study period will be at worst ±4.3%, corresponding to half the 95% confidence interval (CI) of a 50% chance. If the mortality rate were 10%, the precision would be ±2.7%; if the mortality rate were 5%, the precision would be ±2%.

* Pazients admitted to the Fondazione IRCSS Policlinico San Matteo * Diagnosis of bacterial meningitis, meningoencephalitis, bacterial CNS infection, viral CNS infection, viral encephalitis, brain abscess, or post-neurosurgical meningitis.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Italia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Infections

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 23, 2026

Study Start

March 4, 2022

Primary Completion

March 5, 2022

Study Completion (Estimated)

January 1, 2030

Last Updated

January 23, 2026

Record last verified: 2025-09

Locations