ISRCTN97846634已完成不适用
eurological manifestations of dengue: a comparative study of viral, clinical, pathophysiological and genetic factors
niversity of Oxford (UK)0 个研究点目标入组 200 人开始时间: 2008年7月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Aged between 6 months and 16 years, either sex
- •2. Consent given by parents or legal guardians
- •3. History of fever with altered or reduced conscious level (Glasgow coma scale less than or equal to 14) lasting longer than 1 hour
- •4. History of illness of less than 7 days
- •5. One or more of the following on admission:
- •5.1. Hepatomegaly
- •5.2. Skin or any organ bleeding
- •5.3. Platelet count less than 150,000/mm^3
- •5.4. Haematocrit greater than 42%
- •5.5. Serum glutamic oxaloacetic transaminase (SGOT)/prothrombin time (PT) greater than 100
- •5.6. Albumin less than 3.2 g/dL
- •5.7. Positive rapid test for Dengue NS1 (plasma or cerebrospinal fluid [CSF]), or any of the following at Hospital for Tropical Diseases (HTD)/Oxford University Clinical Research Unit (OUCRU):
- •5.7.1. Positive Dengue immunoglobulin M (IgM)/NS1 enzyme-linked immunosorbent assay (ELISA) (plasma or CSF)
- •5.7.2. Positive dengue reverse transcription polymerase chain reaction (RT-PCR) (plasma or CSF)
- •Control group 1:
- •1. First consecutive, age-matched hospitalised dengue patient
- •2. Confirmed by rapid NS1-detection
- •3. Parents/legal guardians give informed consent to participate in the study
- •Control group 2:
- •1. First two consecutive, age-matched patients admitted with suspected viral encephalitis
- •2. Parents/legal guardians give informed consent to participate in the study based on:
- •2.1. History of fever with altered or reduced conscious level lasting longer than 1 hour
- •2.2. History less than 7 days
- •2.3. Two or more of the following signs or symptoms:
- •2.3.1. Seizures*
- •2.3.2. Agitation/delirium/behavioural changes
- •2.3.3. Abnormal movements
- •2.3.4. Facial/limb paresis/paralysis
- •2.3.5. Dysconjugate gaze
- •2.3.6. Extrapyramidal signs/symptoms (e.g. ataxia, tremor, rigidity, masked facies)
- •2.3.7. Neck stiffness
- •2.3.8. Tense fontanel
- •2.3.9. CSF pleiocytosis
- •2.3.10. Electroencephalogram (EEG)/neuroimaging findings consistent with encephalitis, or
- •2.4. Laboratory evidence of viral aetiology of encephalitis
- •*Children between six months and five years with a single convulsion lasting less than 15 minutes who recovered consciousness within 60 minutes are considered to have had a simple febrile convulsion
排除标准
- •1. Bacterial, mycobacterial or parasitological causes as evidenced by microscopy or culture of CSF
- •2. Pre-existing neurological conditions, e.g. cerebral palsy, epilepsy, cerebral infarction/haemorrhage
- •3. Pre-existing chronic liver or renal disease
研究者
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