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Clinical Features and Outcomes of VZV CNS Infections

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07554261
Enrollment
50
Registered
2026-04-28
Start date
2026-04-17
Completion date
2026-09-15
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicella Encephalitis, Varicella Meningitis, Varicella Neurological, Varicella Zoster

Keywords

Varicella Zoster Virus Infection, Encephalitis, Varicella Zoster

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

Interventions

None listed

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of ComplicationsUp to 12 months after diagnosisPresence 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

MeasureTime frameDescription
Functional Outcome (Modified Rankin Scale)Up to 12 months after diagnosisFunctional status assessed using the Modified Rankin Scale (mRS) in patients with VZV CNS infections.
Neurological SequelaeUp to 12 months after diagnosisDevelopment of long-term neurological complications such as epilepsy, cognitive impairment, or motor deficits.
Intensive Care Unit (ICU) RequirementUp to 1 month after diagnosisRequirement for ICU admission during the course of illness.
MortalityUp to 1 month after diagnosisAll-cause mortality related to VZV central nervous system infection.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORÖzlem Güler, MD

Kocaeli University, Kocaeli, Turkey

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026