Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 1,700
- 试验地点
- 8
- 主要终点
- Average antibiotics duration
研究概览
简要总结
The trial is aimed to show that implementation of a procalcitonin-guided antibiotics algorithm may result in shortened antibiotics course in ICU sepsis patients without inferior outcome as compared to the conventional therapy
详细描述
The duration of antibiotic therapy in patients with sepsis is largely empirical. An extended treatment course for up to two weeks is a common practice for patients with sepsis in the ICU, despite lack of evidence for this duration of therapy.
Procalcitonin (PCT) is a new biomarker that has high negative predictive value for systemic bacterial infection. The purpose of this trial is to evaluate whether serial PCT measurements can shorten antibiotic treatment duration in patients with sepsis in the ICU.
Specific Aims
- To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may result in shortened antibiotics course in ICU sepsis patients
- To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may not result in inferior outcome as compared to conventional therapy
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with laboratory- or image-confirmed severe infection at admission or during stay in ICU will be eligible for inclusion.
- •Definition of laboratory- or image-confirmed severe infection:
- •Two or more of four Signs of Inflammation
- •Temperature > 38.3℃ or < 36℃
- •Heart rate > 90 beats/min
- •Respiratory rate > 20 breaths/min or PaCO2 < 32 mmHg
- •WBC > 12,000 cells/mm3, < 4000 cells/mm3, or > 10% bands
- •Initial Procalcitonin > 0.5 ng/mL
- •Presence of either laboratory or image evidence of infection
- •Laboratory evidence:
- •Sign of inflammation in urine, CSF, ascites, pleural effusion or local abscess
- •Image evidence:
- •Compatible findings on Chest X ray、ultrasound、CT、or MR image
排除标准
- •Age less than 20 years
- •Known pregnancy
- •Presence of DNR order
- •Expected ICU stay less than 3 days
- •Neutropenia (ANC count < 500/mm3)
- •Specific infections for which long-term antibiotic treatment is strongly recommended: lung abscess or empyema, bacterial meningitis, osteomyelitis, infective endocarditis, local abscess, mediastinitis
结局指标
主要结局
Average antibiotics duration
时间窗: 28 days
28-day mortality rate
时间窗: 28 days
Safety endpoints
次要结局
- Proportion of antibiotics use in both arms(28 days)
- Length of ICU stay(90 days)
- Recurrence of fever within 72 hours of antibiotics discontinuation(28 days)
- APACHE-II score or SOFA score(28 days)
- Reinfection between 72-hours and 28 days post antibiotics discontinuation(28 days)
- 90-day all-cause mortality(90 days)
- 90-day infection related readmission rate(90 days)