NIHR Global Health Research Group on Brain Infections Study: Establishing a Standard Care Package to Improve Diagnosis and Early Hospital Management of Patients With Suspected Acute Brain Infections in Low and Middle Income Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,233
- 试验地点
- 4
- 主要终点
- Microbiological diagnosis
研究概览
简要总结
Background: Patients with suspected brain infections pose major challenges to low and middle income countries, including their disproportionately high burden, diverse causes with inadequate surveillance, requirement for invasive and expensive tests, and the difficulty of management without a clear diagnosis. This is all compounded by resource and system constraints. Few studies have attempted to improve the care of these people in resource-limited settings.
Aim: This study sets out to improve the diagnosis and early management of people with suspected acute (<28 days of symptoms) brain infections in low and middle income countries, using a coordinated thematic approach.
Outcomes: The primary outcome will be proportion of people with suspected acute brain infection receiving a diagnosis. Secondary outcomes will include mortality, length of stay in hospital, quality of life, degree of disability, and proportion having a lumbar puncture test.
Participants: Children and adults with features consistent with an acute brain infection, including meningitis and encephalitis, will be recruited at a variety of hospitals in Brazil, India and Malawi.
Study procedures: An assessment of current practice and capabilities at each hospital, including patient and sample journey observations and interviews with healthcare staff, will identify barriers to optimal care. Using this, a sustainable pragmatic multi-component intervention will be produced, with components modifiable to each hospital's needs. Outcomes will be reassessed post-intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, infants and children presenting to a study hospital with symptoms and/or signs suggestive of acute brain infection, which could be suspected encephalitis, suspected meningitis, or alternative features raising suspicion of brain infection.
- •Symptom duration of less than 4 weeks.
排除标准
- •Neonates, i.e. children under the age of 28 days.
- •People with pre-existing indwelling ventricular devices (e.g. extra-ventricular drains, ventriculo-peritoneal shunts) or other implants in contact with the meninges or brain (e.g. deep brain stimulators).
- •People without an indwelling device, having undergone neurosurgical procedures within the preceding 12 months.
结局指标
主要结局
Microbiological diagnosis
时间窗: During hospital admission, or at 30 days if participant still in hospital
Proportion of patients achieving microbiological diagnosis
Syndromic diagnosis
时间窗: During hospital admission, or at 30 days if participant still in hospital
Proportion of patients achieving syndromic diagnosis
次要结局
- Length of stay in hospital(During hospital admission, or at 30 days if participant still in hospital)
- Time to appropriate empirical therapy(During hospital admission, or at 30 days if participant still in hospital)
- Mortality(At 30 days)
- Time to appropriate definitive therapy(During hospital admission, or at 30 days if participant still in hospital)
- Quality of life score(At 30 days after presentation to hospital)
- Proportion receiving, and time to lumbar puncture(During hospital admission, or at 30 days if participant still in hospital)
- Proportion having appropriate cerebrospinal fluid investigations(During hospital admission, or at 30 days if participant still in hospital)
- Liverpool Outcome Score(At 30 days after presentation to hospital)
研究者
Tom Solomon
Professor
University of Liverpool