Frail Old Patients With Clostridioides Difficile Infection: Improvement of Quality in Treatment and Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 2
- 主要终点
- 90-day mortality
研究概览
简要总结
CDI is a major cause of antibiotics-associated diarrhoea. More than half of the patients affected are 70 years or older and frail. Mortality among older patients with CDI is high. Faecal microbiota transplantation (FMT) is a life-saving therapy which reduce symptom duration and mortality. The FMT procedure usually requires hospital attendance, and frail old patients often are too weak to tolerate transportation to hospital and may therefore be withheld treatment.
The overall aim of the present project is to investigate whether a multimodal geriatric assessment, treatment and follow-up of frail older patients with CDI can improve patient survival compared with standard care. In particular, it is explored whether an expanded collaboration between the geriatric wards, early clinical assessment and home treatment with FMT contribute to increased patient survival rates.
详细描述
This is a multi-centre randomised clinical trial that test two established care pathways in the assessment and treatment of old patients with Clostridioides difficile infection (CDI). We aim to include 216 patients aged 70 years or older with Clostridioides difficile infection. Patients are randomised in a 1:1 ratio to either geriatric tailored intervention or standard care as defined by national clinical guidelines. The primary outcome is 90-day survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Functional capacity and Overall Quality of life will be performed on both groups by a trained blinded project assistant during planned visits to the patients. The project assistant will be blinded to randomization status in redcap database.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged ≥ 70 years and living in the Central Denmark Region
- •Positive PCR test Clostridioides difficile
排除标准
- •Previously included
- •> 4 episodes of CDI
- •FMT treatment 8 weeks before date of positive PCR test for Clostridioides difficile.
- •End of life care defined as follows: end of life care treatment has been initiated before positive PCR test for CDI and the patient has days/few weeks of survival (investigator consensus based on review of electronic medical journal (EMR))
- •Patients already received Comprehensive Geriatric Assessment, defined as follows: when diagnosed with CDI affiliated with the Department of Geriatrics (in- or outpatient activity).
结局指标
主要结局
90-day mortality
时间窗: Date of 90-day follow-up will include day of positive PCR test for CD and day 90 from date of positive PCR test for CD.
Mortality within 90 days from date of positive Polymerase Chain Reaction (PCR) test for Clostridioides difficile (CD). Date of death will be collected from the electronic medical journals according to date of death registration.
次要结局
- Physical functional status(83-97 weekdays after date of positive PCR test for Clostridioides difficile.)
- Overall quality of life assessed by Depression List(83-97 weekdays after date of positive PCR test for Clostridioides difficile.)
- Quality of life assessed by the 5-level EQ-5D Interviewer version(83-97 weekdays after date of positive PCR test for Clostridioides difficile.)
- Quality of life assessed by the 5-level EQ-5D proxy 2 version(83-97 weekdays after date of positive PCR test for Clostridioides difficile.)