2024-519024-25-00招募中2 期
Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients – Randomised Controlled Trial
Fakultni Nemocnice Kralovske Vinohrady1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年12月3日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Percentage of patients with treatment failure at day 7 after randomisation.
研究概览
简要总结
Percentage of patients with treatment failure at day 7 after randomisation. Treatment failure is defined as either failure to administer allocated treatment for any reason or the presence of diarrhoea on day 7 after randomisation.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Age > 18 yrs.
- •In-patient in ICU or HDU (incl. burn unit) and expected to stay for >7 days
- •Diarrhoea following antibiotic treatment defined as 3 or more stools per day or Bristol type 7 stool in the volume >300 ml/day if stool derivative device is in place, persisting for 24 hours despite enteral feeding formula has been stopped
排除标准
- •Death appears imminent or ceilings of care put in place, presence of new-onset sepsis defined as per 2016 definition, lactate >2.0 mM, colon diameter > 9 cm on plain AXR, the necessity of ongoing antibiotic treatment for another reasons.
- •Unable to tolerate enema for any reason (e.g. surgery of the GI tract in the past year).
- •Pregnant and lactating woman
- •Patients with a history of severe anaphylactic food allergy, any other reason which – as per judgement of the treating clinician – makes faecal transplantation unsafe or not feasible
结局指标
主要结局
Percentage of patients with treatment failure at day 7 after randomisation.
Percentage of patients with treatment failure at day 7 after randomisation.
次要结局
- Composite number of adverse events such as new-onset sepsis, toxic mega-colon, positive post FBT blood culture, or other SAE assessed by the physi-cian-in-charge as possibly related to FBT.
- SOFA score at days 4 and 7.
- Percentage of patients that are recurrence-free at time of hospital discharge or day 28, whichever occur earlier.
- Subgroup analysis will be performed for patients who are C. dif. positive vs. negative and those who will receive antibiotics for a new extraabdominal in-fection vs. those who do not.
研究者
Dr Frantisek Duska, PhD
Scientific
Fakultni Nemocnice Kralovske Vinohrady
研究点 (1)
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