Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 630
- 试验地点
- 2
- 主要终点
- Exposition to antibiotics, defined by antibiotic-free days
研究概览
简要总结
The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.
详细描述
Clinical and laboratory signs are neither specific nor sensitive for diagnosis of sepsis in critically-ill patients. Because delaying antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in ICU -patients, even when they are not needed. In addition, only few well-designed studies concerning the duration of antibiotic treatment have been so far published. Consequently, many patients received antibiotics during the ICU stay. Many studies have shown that exposure to antibiotics, the so called "selection pressure" is an independent risk factor for acquisition of resistance in individual patients. Therefore, reducing antibiotic use is probably necessary to control antibiotic resistance. Many clinical studies have shown that procalcitonin (PCT) is able to distinguish the inflammatory response to infection from other types of inflammation and to distinguish bacterial from viral infections. Recent studies have shown that PCT guidance substantially and safely reduced antibiotic overuse in patients with lower respiratory tract infections. We aimed to evaluate the role of PCT in reducing the use of antibiotics in ICU adult patients. The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient hospitalised in the ICU
- •Bacterial infection suspected
- •At ICU admission the patient do not receive antibiotics or receive antibiotics for less than 24hours and an interval between admission and inclusion < 12 hours
- •During ICU stay, provided that the interval between the start of suspected infection and inclusion is < 12hours
- •Written inform consent from the patient or relatives. The consent may be obtained after the enrollment if the patient is not able to give consent and if there is no relatives
排除标准
- •Age < 18 years
- •Pregnancy
- •Patient expected to remain hospitalised in the ICU for less than 3 days
- •Neutropenia
- •Infection or presumed infection requiring prolonged antibiotic therapy (endocarditis,osteo-articular infection, mediastinitis, deep abscess, tuberculosis, pneumocystis pneumonia, toxoplasmosis).
- •Simplified Acute Physiology Score II at ICU admission (calculated during the first 12h)
- •Attending physician declining to use full life support.
结局指标
主要结局
Exposition to antibiotics, defined by antibiotic-free days
时间窗: assessed 28 days after inclusion
Mortality
时间窗: at Day 28 and Day 60
次要结局
- Consumption of antibiotics expressed as the Defined Daily Dose/1000 ICU-days(between D1 and D28)
- The length of ICU and hospital stay(during the stay at the hospital)
- The evolution of SOFA score parameters(between D1 and D28)
- The number of mechanical ventilation-free days(at D28)
- The acquisition cost of antibiotics(between D1 and D28)
- The percentage of emerging multiresistant bacteria between D1 and D28, as assessed by microbiologic examination of all clinical samples.(between D1 and D28)
- The percentages of relapses of infection(between D1 and D28)