Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 7
- 主要终点
- Delirium at day 7 or at day of hospital discharge, whichever is earliest
研究概览
简要总结
Delirium is an acute confusional state that is experienced by many older adults who are admitted to hospital. To treat delirium the underlying cause needs to be identified promptly, but this is challenging. One of the potential causes of delirium is infection. Urine tests show that most patients experiencing delirium have bacteria in their urine, however, bacteria in the urine is common among older adults, and does not automatically indicate an infection is present. As a result it is difficult to know whether a lower urinary tract infection is present as individuals with delirium are frequently unable to report clinical signs of infection - symptoms of pain or discomfort with urination, having to urinate more frequently or pelvic discomfort. Very often, individuals with delirium are treated with antibiotics despite the fact that it is unknown whether antibiotics help to improve delirium in cases where bacteria in the urine is present. This proposed study is a randomized controlled trial that will examine if adults (age 60 or older) with delirium and suspected infection benefit from taking antibiotics.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Antibiotics
Participants will be randomized to start or continue with antibiotics. Antibiotic type and duration targeted to lower urinary tract infection as directed by the Most Responsible Physician (MRP).
干预措施: Start Antibiotics / Continue Antibiotics for treatment of bacteriuria (Drug)
No Antibiotics
Participants will be randomized to no antibiotics
干预措施: No Antibiotics for treatment of bacteriuria (Other)
结局指标
主要结局
Delirium at day 7 or at day of hospital discharge, whichever is earliest
时间窗: Delirium will be assessed at the first of day 7 or discharge
Delirium will be assessed using Confusion Assessment Method (CAM). CAM assesses 4 delirium features: \[1\] inattention, \[2\] acute and fluctuating level of consciousness, \[3\] disorganized thinking and \[4\] altered mental status. For a diagnosis of delirium by CAM, the patient must display feature \[1\] AND \[2\], AND EITHER \[3\] or \[4\].
次要结局
- Length of hospitalization(Up to 30 days)
- Number of participants with bacteremia (bacteria isolated in blood culture)(Up to 7 days)
- Number of participants who were transferred to Intensive Care Unit (ICU)(Up to 7 days)
- Number of participants who had a fall(Up to 7 days)
- Number of participants who received antipsychotics(Up to 7 days)
- Number of participants with C. difficile infection(By 30 days)
- Number of participants who died(By 365 days)
- Number of participants who were readmitted to hospital(By 30 days)
- Number of participants who were physically restrained(Up to 7 days)
- Days of antibiotics(Up to 7 days)