Impact of a Strategy Based on the Unyvero® Testing System on Appropriate Antimicrobial Treatment in Patients With Suspected Aspiration Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 266
- 试验地点
- 2
- 主要终点
- The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment
研究概览
简要总结
The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results of microbiological results, usually performed before starting antimicrobial treatment. However, in most hospitals, 48-72h are required to obtain the results of microbiological cultures, and to de-escalate empirical large spectrum antibiotic treatment.
The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory bacterial pathogens would allow decreasing the percentage of patients with aspiration syndrome who will receive unappropriated antibiotic treatment at Day 3.
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 (Participant)
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
- •presence of risk factors for aspiration :
- •known or likely swallowing dysfunction,
- •altered consciousness,
- •cardiac arrest,
- •difficult intubation
- •witnessed aspiration
- •symptoms and signs suggestive of lower respiratory tract pathology
- •temperature ≥38.5°C or <36°C
- •leukocyte count ≥10 000/µL or <1500/µL
- •purulent sputum or tracheal aspirate.
- •new radiographic infiltrate on chest X-ray
- •tracheal intubation and mechanical ventilation since less than 48 hours
排除标准
- •pregnant women
- •refuse to participate to the study
- •no informed consent
- •documented bacteremia
- •septic shock
- •severe immunosuppression: leukocytes<1000/L or neutrophils<500/L, chemotherapy during the last 3 months, organ transplant with chronic immunosuppressors use, HIV (CD4<50), and chronic corticosteroid use (>0.5 mg/kg day for at least one month during the last three months).
- •moribund patients (SAPS II >90).
研究组 & 干预措施
standard strategy
干预措施: Standard microbiological diagnosis strategy (Procedure)
multiplex PCR strategy
FilmArray® Pneumonia Panel plus
干预措施: PCR-based microbiological diagnosis strategy (Procedure)
结局指标
主要结局
The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment
时间窗: 48 hours after antibiotic treatment initiation
次要结局
- length of ICU stay.(up to Day 90)
- ICU mortality.(up to Day 90)
- percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR)(at Day 28 and Day 90 after antibiotic treatment initiation)
- the percentage of patients who will receive targeted antibiotic treatment.(at Day 28 and Day 90 after antibiotic treatment initiation)
- antibiotic free days.(up to Day 90)
- the percentage of patients who will receive appropriate antibiotic treatment.(at Day 28 and Day 90 after antibiotic treatment initiation)
- mechanical ventilation free days.(at Day 28 and Day 90 after antibiotic treatment initiation)