Trial of Short-Course Antimicrobial Therapy for Sepsis in Intensive Care
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 320
- 试验地点
- 4
- 主要终点
- sepsis-related organ dysfunction
研究概览
简要总结
The purpose of this study is to compare the effect of a short course antimicrobial therapy (5-days) versus a 10-days therapy on sepsis-related organ dysfunction.
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 (Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received antibiotics for presumed infection
排除标准
- •Prolonged therapy (eg, endocarditis)
- •Severe immunosuppression
- •Severe infections (due to viruses, parasites, or Mycobacterium tuberculosis)
- •Patients previously infected or colonized with multidrug resistant pathogens and moribund patients.
研究组 & 干预措施
Group 5-days
5-days targeted antibiotic therapy
干预措施: Antibiotic (Drug)
Group 10-days
10-days targeted antibiotic therapy
干预措施: Antibiotic (Drug)
结局指标
主要结局
sepsis-related organ dysfunction
时间窗: 14-days
Score used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The Sequential Organ Failure Assessment (SOFA) score numerically quantifies the number and severity of failed organs. Higher values represent worse outcome. A score of 0 is given for normal function through to 4 for most abnormal. The systems studied are: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal.
次要结局
- Hospital mortality(30-days)
研究者
Vincenzo De Santis
Medical Doctor
Ospedale Santa Maria delle Croci