EARLY Antibiotics aDaptation in Ventilator-Acquired-Pneumonia Treatment After Implementation of a Broad-Panel Respiratory Multiplex PCR Test: A Multicenter Randomized Control Trial Conducted In Swiss Intensive Care Units. The EARLY ADAPT Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 170
- 试验地点
- 6
- 主要终点
- The primary outcome is the broad-spectrum antibiotic-free hours at day 7 from inclusion
研究概览
简要总结
The objective of the study is to determine whether rapid multiplex PCR testing of respiratory samples can reduce exposure to broad-spectrum antibiotics in intensive care unit patients with suspected or confirmed ventilator-associated pneumonia, compared to standard diagnostic methods.
As secondary objectives, the investigators will study antibiotic management and overall antibiotic consumption, as well as escalation or de-escalation events. The investigators will study the potential clinical impact of using multiplex PCR to see if the length of stay in the intensive care unit is reduced, as well as the duration of mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patients (≥ 18 years old)
- •Hospitalized in intensive care with invasive mechanical ventilation ≥ 48 hours
- •Administration of antimicrobial therapy for suspected VAP at the time of inclusion.
- •Expected survival > 96 hours.
排除标准
- •Enrollment prior to the current trial
- •Participation in an interventional study on the management of AMR that has a direct impact on antibiotic therapy practices.
结局指标
主要结局
The primary outcome is the broad-spectrum antibiotic-free hours at day 7 from inclusion
时间窗: Seven days
It is defined as the time, measured in hours, that the patient is alive and not treated with broad-spectrum antibiotics (≥ class 4 of ß-lactam according to Weiss et al.) within a period during from the date of randomization to day 7 or earlier if ICU discharge.
次要结局
- Median time (in hours) on broad-spectrum antibiotics during ICU stay.(28 days)
- Antibiotic free days defined as the number of days alive without antibiotics at Day 14 and Day 28.(28 days)
- Time to antimicrobial switch (time to de-escalation or escalation) measured in hours.(Seven days)
- Rate of appropriate antimicrobial therapy at the following time points: inclusion, 24h after inclusion and 48h after inclusion.(48 hours)
- ICU mortality and hospital mortality at Day 28(28 days)
- Ventilator free-days until Day 28(28 days)
- ICU length of stay(28 days)
- Rate of adherence to antimicrobial guidelines at 48h.(48 hours)
研究者
Christophe Le Terrier
Investigator coordinator and Attending Physician in ICU
University Hospital, Geneva