ISRCTN06886935已完成未知
Development and evaluation of an intervention based around the national guidelines on the management of suspected encephalitis, and its evaluation through a cost-effectiveness analysis
niversity of Liverpool (UK)0 个研究点目标入组 1,680 人开始时间: 2013年7月22日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,680
研究概览
简要总结
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25623603 2015 results in: http://www.implementationscience.com/content/10/1/37 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30521521
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Site inclusion criteria:
- •All centres will have a consultant and all centres must be equipped with the ability to perform, or have access to CT/MRI scans and have aseptic conditions for conducting a LP to be performed. Hospitals will be randomised as a unit to either the standard care or intervention arm. Study centres will be initiated once all global (e.g. local research and development [R&D] approval) and study-specific conditions (e.g. training requirements) have been met, and all necessary documents have been returned to the Brain Infections UK coordinating centre.
- •Within this study, any patients who have suspected encephalitis within the recruited sites will be included in the study. The inclusion criteria for suspected encephalitis are:
- •Patients with suspected encephalitis
- •(a) Mandatory
- •Acute or sub-acute (<4 weeks) alteration in consciousness, cognition, personality or behaviour persisting for more than 24 hours. Personality/behaviour change includes: agitation, psychosis, somnolence, insomnia, catatonia, mood liability, altered sleep pattern and (in children): new onset enuresis, or irritability.
- •Plus ANY two of:
- •1. Fever (> 38ºC) / prodromal illness ? acute or sub-acute
- •2. Seizures: new onset
- •3. Focal neurological signs ? acute or sub-acute onset. These include:
- •3.1. Focal weakness
- •3.2. Oromotor dysfunction
- •3.3. Movement disorders (chorea, athetosis, dystonia, hemiballisms, stereotypies, orolingual dyskinesia and tics) including Parkinsonism (bradykinesia, tremor, rigidity and postural instability)
- •3.4. Amnesia
- •4. Pleocytosis: cerebrospinal fluid white cell count >4 cells/ul
- •5. Neuroimaging: compatible with encephalitis
- •6. Electroencephalogram (EEG): compatible with encephalitis
- •(b) Clinical suspicion of encephalitis but above investigations have not yet been completed
- •(c) Clinical suspicion of encephalitis and the patient died before investigations completed
- •Target Gender: Male & Female
排除标准
- •Site exclusion criteria:
- •Current participation in the ENCEPH UK programme
- •Added 07/01/2015:
- •Patient exclusion criteria
- •Any patient aged under 28 days upon the date of admission shall be excluded
研究者
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