跳至主要内容
临床试验/NCT02086916
NCT02086916已完成不适用

Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection

Barts & The London NHS Trust1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
1
主要终点
Failure of primary treatment

研究概览

简要总结

Acquiring diarrhoea in hospital is a serious problem and most frequently occurs when susceptible patients receive antibiotics as part of their (often life-saving) care. The commonest cause is Clostridium difficile - a bacterium that normally lives in up to a third of us but causes no problems. Rates of infection had been falling with increased awareness and improved hygiene but they are starting to creep up again. Clostridium difficile can cause a range of disease from a short-lived mild diarrhoea to severe disease of the bowel with major effects on the whole body and even death.

This study aims to identify substances in the stool and in the blood to enable doctors to predict how severe that individual's disease will be. These tests can easily be performed. If they prove accurate in identifying the subsequent severity of the patient's illness due to Clostridium difficile, patients predicted to develop the worst disease can receive the most intensive treatments before they become too unwell to benefit. On the other hand, patients whose disease is predicted by these markers to run its course without causing serious consequences can be spared the side effects and risks of more intensive treatment.

详细描述

Clostridium difficile infection (CDI), which is often a consequence of antibiotic therapy, is the most common and one of the most serious hospital-acquired illnesses. It causes a range of intestinal upset from mild diarrhoea to a life-threatening severe colitis. The incidence, recurrence and mortality rates of CDI have increased dramatically in recent years. Metronidazole is the recommended first-line antibiotic, with vancomycin and colectomy reserved for severe cases.

Although risk factors for developing CDI are well known, factors that predict outcome and/or recurrence of CDI are uncertain and lack specificity for intestinal inflammation. We wish to investigate if careful prospective monitoring of standard clinical and biochemical measures will be able to identify patients who will go on to fail primary treatment.

If one or more of these factors proves able to predict outcome, they could ultimately be used for early escalation of therapy with the aim of reducing morbidity, mortality and length of hospital stay.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Test positive for CDI on stool analysis
  • Inpatient at Barts Health NHS Trust at time of diagnosis

排除标准

  • Nil specific

结局指标

主要结局

Failure of primary treatment

时间窗: 1 week from diagnosis

Failure of primary treatment Ongoing diarrhoea (day 5), treatment escalation (within 5 days), colectomy for CDI (on index admission), death (on index admission)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验