Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 6
- 主要终点
- Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score
研究概览
简要总结
Development of stroke associated pneumonia (SAP) has a detrimental effect on stroke outcome. Biomarker-guided antibiotic treatment of patients at high risk for pneumonia may help to improve stroke outcome. Therefore, the investigators will evaluate whether intensified infection monitoring via Procalcitonin guiding an early standardized antibiotic treatment improves functional outcome after stroke compared with standard therapy based on current guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •stroke onset within the last 40 hours before randomisation
- •clinical diagnosis of a severe (NIHSS > 9), non-lacunar stroke in the middle cerebral artery territory
- •consent given by the patient or by his/her legitimate representative where patients are incapable of giving consent themselves
排除标准
- •CT evidence of an intracerebral haemorrhage or a lacunar infarct as the probable cause of the current illness
- •Antibiotic use within the last 10 days
- •Suspected life expectancy of < 3 months
- •Participation in other interventional trials (on pharmaceuticals or medical devices)
- •Pregnancy, lactation
- •Pre-stroke mRS score ≥ 4
结局指标
主要结局
Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score
时间窗: 3 months after onset of symptoms (stroke)
To assess the proportion of patients with a modified Rankin scale (mRS 0-6) score 0-4 at day 90 adjusted for baseline modified Rankin score.
次要结局
- Hospital discharge disposition(on discharge)
- Barthel Index adjusted for baseline Barthel Index(6 months after onset of symptoms (stroke))
- Time to first event of death, re-hospitalization or recurrent stroke(within 6 months after onset of symptoms (stroke))
- Proportion of events of post stroke infections(within 7 days after onset of symptoms (stroke))
- Proportion of events of post stroke infection or death(within 7 days after onset of symptoms (stroke))
- Medium number of days with fever (≥ 37,5°C) per patient(within 7 days after onset of symptoms (stroke))
- Stroke volume analysis(6 months after onset of symptoms (stroke))
- Modified Rankin scale adjusted for baseline modified Rankin score(6 months after onset of symptoms (stroke))
- Days alive and out of hospital(3 months after onset of symptoms (stroke))
- Proportion of patients receiving any antibiotic therapy(3 months after onset of symptoms (stroke))
- Modified Rankin scale (mRS) score 0-4 adjusted for baseline modified Rankin score(6 months after onset of symptoms (stroke))
- Length of hospital stay(on discharge)
- shift analysis of the mRS
研究者
Andreas Meisel
Prof. Dr. Andreas Meisel, Charité University, Berlin, Germany (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Charite University, Berlin, Germany