Singapore Neurologic Infections Program
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Incidence rate of the various infective etiologies causing CNS infections in Singapore
研究概览
简要总结
Worldwide, central nervous system infections such as inflammation of brain (encephalitis), inflammation of meninges (meningitis) and sudden onset of weakness of muscles which maybe infectious in origin result in significant illness and death and healthcare costs. Vast majority of central nervous system infections remain without an identifiable cause. There is also concern about new and emerging infections.
This study thus intends to fill in the gaps in knowledge with regards to central nervous system infections in Singapore to give a thorough description of burden of causes of central nervous system infections and detection of outbreaks of new pathogens. Patients suspected of central nervous system infection will be recruited from 5 restructured Singapore hospitals and their blood and other clinical specimens will be sent for testing. Patients will also be followed up to assess long term outcomes and socio-economic costs of these infections. This will help clinicians, policymakers and public health officials in estimating financial and societal costs of CNs infections in Singapore.
详细描述
The study aims to:
- To describe the epidemiology of CNS infections in Singapore.
- To improve the diagnosis of aetiologies of CNS infections through a systematic clinical, laboratory and neuro-radiological evaluation and extensive diagnostic testing.
- To evaluate the prognosis, long-term outcomes and socio-economic costs of CNS infections.
- To establish an archive of biological tissues from patients with encephalitis and CNS infections that can be utilized for future testing for emerging novel pathogens or non-infectious aetiologies.
The study will recruit 400 patients over 2 years from 5 restructured hospitals in Singapore. As this is not a comparative study, sample size was not determined.
The study involves clinical and laboratory data collection. Data will also be collected on quality of life and for health economic analysis. The quality of data and its integrity will be periodically reviewed by the Principal Investigator and members of the study team. All samples stored will be de-identified and all data will be de-identified during analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical suspicion for Central Nervous system (CNS) infections, OR
- •Any two of the following,
- •Fever or history of fever (≥ 38 °C) during the presenting illness
- •Seizures of new onset
- •Focal neurological deficits
- •Cerebrospinal fluid white cell count pleocytosis (> 4 White blood cells (WBC)/uL)
- •Abnormal neuroimaging suggestive of CNS infection.
- •Abnormal electroencephalogram (EEG) suggestive of CNS infection
- •Depressed or altered level of consciousness, OR
- •No alternative aetiology for acute paralysis identified (e.g stroke, trauma, myopathy etc)
排除标准
- •Patient or next of kin unwilling to give consent
- •Patients with indwelling ventricular devices such as EVD (external ventricular drain), VP (ventriculo-peritoneal) shunts
结局指标
主要结局
Incidence rate of the various infective etiologies causing CNS infections in Singapore
时间窗: 36 months
Annual rates of the various infective causes from year 2013 to year 2016
次要结局
- Clinical characteristics of patients diagnosed with CNS infections: .(Day1- Day180)
- Clinical course of patients with CNS infections,(Day1-Day180)
- Clinical features of patients with CNS infections in Singapore(Between D1(day of recruitment)-D180(last day of follow up))
- Treatment modalities of the CNS infections(Day 1-Day 180)