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CompletedNCT07554261Updated Oct 7, 2026

Clinical Features and Outcomes of VZV CNS Infections

An observational study in Varicella Zoster, Varicella Meningitis and Varicella Encephalitis, sponsored by Kocaeli University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Kocaeli University · Observational

Updated Oct 7, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
59
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Varicella zoster virus (VZV) is a well-established cause of central nervous system infections, including meningitis and encephalitis, which may lead to significant morbidity and mortality. These infections can occur with or without the typical dermatomal rash and may present with a wide spectrum of neurological findings. With increasing life expectancy and the widespread use of immunosuppressive and immunomodulatory therapies, the incidence of VZV reactivation and related complications is expected to rise.

Despite advances in molecular diagnostic methods, which have improved the timely and accurate detection of VZV in cerebrospinal fluid, large-scale multicenter data on VZV-related central nervous system infections remain limited, particularly at the national level.

This multicenter retrospective cohort study aims to evaluate the clinical features, risk factors, and functional outcomes of adult patients diagnosed with VZV meningitis and encephalitis. Data will be collected from participating centers using a standardized dataset, including demographic characteristics, clinical presentation, comorbidities, laboratory findings, cerebrospinal fluid analysis, imaging results, treatment details, and follow-up outcomes.

The study will compare patients with and without complications to identify factors associated with adverse outcomes. Complications assessed during follow-up (minimum 1 month, up to 12 months) will include neurological sequelae such as epilepsy, cognitive impairment, cranial nerve deficits, and functional disability measured by the Modified Rankin Scale. Mortality and intensive care unit requirements will also be evaluated.

Statistical analyses will be performed to determine associations between clinical variables and outcomes. Categorical variables will be compared using chi-square or Fisher's exact tests, and continuous variables will be analyzed according to their distribution. Logistic regression models will be used to identify independent predictors of complications. A p-value of \<0.05 will be considered statistically significant.

The study will be conducted under the coordination of the Association of Infectious Diseases and Clinical Microbiology Specialists (BUHASDER).

02

Conditions studied

  • Varicella Zoster
  • Varicella Meningitis
  • Varicella Encephalitis
  • Varicella Neurological

Keywords

  • Varicella Zoster Virus Infection
  • Encephalitis, Varicella Zoster
03

In context

Varicella Zoster Virus Infection

22 studies on the registry are indexed under Varicella Zoster Virus Infection; 3 are open to participants now.

Browse Varicella Zoster Virus Infection studies →

Lead sponsor

Kocaeli University is the lead sponsor of 210 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Missing key clinical data Inadequate follow-up

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
59 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

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.

    Time frame: Up to 12 months after diagnosis

Secondary outcomes

  1. Functional Outcome (Modified Rankin Scale)

    Functional status assessed using the Modified Rankin Scale (mRS) in patients with VZV CNS infections.

    Time frame: Up to 12 months after diagnosis

  2. Neurological Sequelae

    Development of long-term neurological complications such as epilepsy, cognitive impairment, or motor deficits.

    Time frame: Up to 12 months after diagnosis

  3. Intensive Care Unit (ICU) Requirement

    Requirement for ICU admission during the course of illness.

    Time frame: Up to 1 month after diagnosis

  4. Mortality

    All-cause mortality related to VZV central nervous system infection.

    Time frame: Up to 1 month after diagnosis

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Study locations

1 site
  • Kocaeli University
    İzmit, Kocaeli 41380, Turkey (Türkiye)
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References and documents

Publications

  • 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. PubMed 39865326 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 7, 2026
Primary completion
Sep 1, 2026→Oct 6, 2026 (actual)
Oct 7, 2026
Study completion
Sep 15, 2026→Oct 6, 2026 (actual)
Oct 7, 2026
Enrollment
50 (estimated)→59 (actual)
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Active, not recruiting→Completed
    Primary completion Sep 1, 2026→Oct 6, 2026 (now actual)
    Study completion Sep 15, 2026→Oct 6, 2026 (now actual)
    Enrollment 50 (estimated)→59 (actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07554261
Lead sponsor
Kocaeli University
Responsible party
Özlem Güler (Assistant Professor M.D., Kocaeli University) — Principal investigator
First posted
Apr 28, 2026
Start date
Apr 17, 2026
Primary completion
Oct 6, 2026
Completion
Oct 6, 2026
Last update
Oct 7, 2026

Study contacts

Özlem Güler, MD
principal investigator · Kocaeli University, Kocaeli, Turkey

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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