Prospective Investigation of Oxidative Stress in West Nile Virus Infection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Ophthalmological abnormalities
研究概览
简要总结
The investigator hypothesizes that oxidative stress responses to West Nile virus infection in the central nervous system determine the severity of infection and the long-term neurological, neuropsychological and functional sequelae of West Nile Neuroinvasive Disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide written informed consent. If the clinical condition of the patient does not permit giving consent, informed consent will be obtained from the next of kin.
- •Age 18 years or older
- •for active cases: positive anti-WNV IGM antibodies in serum (or IgG in CSF if applicable)
- •for active cases: presentation within (maximum) 7days of symptom onset
- •for healthy controls: anti-WNV antibody naive (IgM and IgG in serum). The group of healthy controls will be selected to have an age similar distribution to the cases.
排除标准
- •Evidence of active systemic infection in 3 months prior to recruitment
- •Evidence of systemic inflammatory illness
- •Clinical signs of neurodegenerative or neurologic disease other than WNND
- •Pregnancy
- •Active malignancy
- •History of drug abuse
结局指标
主要结局
Ophthalmological abnormalities
时间窗: at recruitment, with a follow-up of clinically indicated.
As part of the descriptive analysis of clinical markers of disease severity ophthalmologic abnormalities will be assessed by slit lamp examination
serum S100b concentration
时间窗: at recruitment, 10 days post symptom onset and 20 days post symptom onset
As part of the descriptive analysis of clinical markers of disease severity S100b concentration will be measured to asses the Blood-Brain barrier integrity
serum NSE concentration
时间窗: at recruitment, 10 days post symptom onset and 20 days post symptom onset
As part of the descriptive analysis of clinical markers of disease severity NSE concentration will be measured to asses the Blood-Brain barrier integrity
Measure the redox status
时间窗: at recruitment, 10 days post-symptom onset and 20 days post symtom onset.
A multiparameter indexes of oxidative stress will be calculated to measure and summarize the redox status in cases and age matched controls. Association between the redox status and clinical, neuropsychological and radiological outcomes will be investigated. We will also examine the relative sensitivity of separate biomarkers of oxidative stress and autophagy as clinical predictors of WNV infection severity.
Assessment of Neurologic deficits
时间窗: At recruitment, month 3 and month 12
As part of the descriptive analysis of biomarkers of disease severity and to study to neurologic sequelae of WNV infection. Will be assessed: specifically assessments of cranial nerves II- XII, motor strength in upper and lower extremities, sensory testing for pinprick and vibration, deep tendon reflexes, gait, coordination, and movement abnormalities
Longitudinal assessment of functional status Study the neurologic and neuropsychologic sequelae of WNV infection during a 12-month followup period.
时间窗: at recruitment, month 3 and month 12
ECOG/WHO PS during a 12-month followup.
Neuropsychologic performance
时间窗: 20 days post-symtom onset, month 3 and month 12
Study the neuropsychologic sequelae of WNV infection during a 12-month followup period in following key domains: Attention, Memory, Executive Function, Emotion \& Social Cognition, Psychomotor Speed
MRI abnormalities
时间窗: at recruitment, month 3 and month 12
Part of descriptive analysis of clinical markers of disease severity
Brain iron content
时间窗: at recruitment, month 3 and month 12
Part of the descriptive analysis of clinical markers of disease severity: Qualitative analysis per neuroanatomical region by iron-sensitive MRI sequence (SWI)
次要结局
- Analysis of laboratory performance characteristics (e.g. sensitivity) of WNV-specific RT-PCR and viral isolation in clinical samples, compared to composite diagnosis of WNV infection(20 days)
- Description of molecular epidemiology of infecting WNV strain(s) and viral outgrowth diagnostic performance.(20 days)
- Identification of potential genetic signatures that correlate with virulence (neuro-invasion and morbidity) in our cohort.(20 days)