NCT07554261

Brief Summary

The goal of this observational study is to learn about the clinical characteristics, risk factors, and long-term outcomes of varicella zoster virus (VZV)-related central nervous system (CNS) infections in adults. The main questions it aims to answer are: What are the risk factors associated with VZV meningitis and encephalitis? Which clinical and laboratory findings are associated with complications and poor functional outcomes? Researchers will collect retrospective data from participating centers across the country, including demographic, clinical, laboratory, imaging, and treatment variables. Participants diagnosed with VZV-related central nervous system infections will be followed through medical records, and outcomes such as complications, functional status, and mortality will be evaluated.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

April 17, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 17, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 17, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

Varicella Zoster Virus InfectionEncephalitis, Varicella Zoster

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Complications

    Presence of complications in patients with varicella zoster virus (VZV)-related central nervous system infections, including neurological sequelae such as epilepsy, cognitive impairment, cranial nerve deficits, functional disability, or death.

    Up to 12 months after diagnosis

Secondary Outcomes (4)

  • Functional Outcome (Modified Rankin Scale)

    Up to 12 months after diagnosis

  • Neurological Sequelae

    Up to 12 months after diagnosis

  • Intensive Care Unit (ICU) Requirement

    Up to 1 month after diagnosis

  • Mortality

    Up to 1 month after diagnosis

Study Arms (2)

Patients with Complications

Adult patients diagnosed with varicella zoster virus (VZV)-related central nervous system infections who developed complications during follow-up. Complications include neurological sequelae such as epilepsy, cognitive impairment, cranial nerve deficits, functional disability, or mortality.

Patients without Complications

Adult patients diagnosed with varicella zoster virus (VZV)-related central nervous system infections who did not develop complications during the follow-up period.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (≥18 years) diagnosed with varicella zoster virus (VZV)-related central nervous system infections, including meningitis and encephalitis, identified from participating centers. Patients are included based on molecular confirmation of VZV in cerebrospinal fluid and availability of clinical follow-up data.

You may qualify if:

  • Age ≥18 years Molecular confirmation of VZV (PCR-Polymerase Chain Reaction) in CSF fluid Diagnosis of meningitis or encephalitis

You may not qualify if:

  • Missing key clinical data Inadequate follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

İzmit, Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (1)

  • Tyrberg T, Hagberg L, Nilsson S, Grahn A. Incidence and Risk Factors for Varicella-Zoster Virus-Associated Central Nervous System Infections: A Nationwide Swedish Retrospective Case-Control Study. J Med Virol. 2025 Feb;97(2):e70166. doi: 10.1002/jmv.70166.

    PMID: 39865326BACKGROUND

MeSH Terms

Conditions

Encephalitis, Varicella ZosterVaricella Zoster Virus Infection

Condition Hierarchy (Ancestors)

Encephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisVirus DiseasesHerpesviridae InfectionsDNA Virus InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • Özlem Güler, MD

    Kocaeli University, Kocaeli, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor M.D.

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 28, 2026

Study Start

April 17, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 7, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations