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Clinical Trials/NCT07554261
NCT07554261Active, not recruitingNot Applicable

Clinical Features, Risk Factors, and Functional Outcomes of Varicella Zoster Virus Central Nervous System Infections: A BUHASDER Multicenter Retrospective Cohort Study

Kocaeli University1 site in 1 country50 target enrollmentStarted: April 17, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
50
Locations
1
Primary Endpoint
Occurrence of Complications

Study Overview

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.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Missing key clinical data Inadequate follow-up

Arms & Interventions

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.

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.

Outcomes

Primary Outcomes

Occurrence of Complications

Time Frame: Up to 12 months after diagnosis

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Özlem Güler

Assistant Professor M.D.

Kocaeli University

Study Sites (1)

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