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OpenTrials
Active, Not Recruiting

NCT Number: NCT07554261

Clinical Features and Outcomes of VZV CNS Infections

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Functional Outcome (Modified Rankin Scale)

    Time frame: Up to 12 months after diagnosis

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

  2. Neurological Sequelae

    Time frame: Up to 12 months after diagnosis

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

  3. Intensive Care Unit (ICU) Requirement

    Time frame: Up to 1 month after diagnosis

    Requirement for ICU admission during the course of illness.

  4. Mortality

    Time frame: Up to 1 month after diagnosis

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

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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