PK/PD Target Attainment of Ceftriaxone for the Prevention of Early Ventilator-associated Pneumonia in Neurologically Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of patients with PK/PD target attainment
研究概览
简要总结
Critically ill patients admitted for acute brain injury are exposed to many heath-care associated infections such as ventilator associated pneumoniae (VAP). The PROHYVAP study, published in 2024 reported that a single dose of CEFTRIAXONE as an antibiotic prophylaxis could reduce the incidence of early VAP (VAP that occured between day 2 and day 7 of mechanical ventilation).
However, patients with acute brain injury also presented frequently augmented renal clearance (ARC), which could affect the pharmacokinetic and pharmacodynamic target attainment (PK/PD) of antibiotic prophylaxis.
This study aims to analyse the PK/PD target attainment after one dose of CEFTRIAXONE in critically ill patients with acute brain injury and to describe the effect of ARC on PK/PD target attainment during early VAP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years or older
- •Admitted in intensive care unit for acute brain injury, including traumatic brain injury and cerebral vascular disease
- •Glasgow coma scale inferior to 12
- •Orotracheal intubation in first 12 hours of admission
- •Needed of invasive mechanical ventilation for at least 48 hours
排除标准
- •Acute brain injury related to tumoral or infectious process
- •Antibiotic therapy administered before acute brain injury for an other pathology
- •Patients with a risk of multiresistance bacteria contamination (stay in a risk area in the past 3 months, antibiotic therapy with fluoroquinolone or betalctamine in the past 3 months, hospitalization in last month before admission, documented contaminationwith multiresistance bacteria, immunodepression)
- •Patients with hish risk of death in the first 48 hours
- •Patients with a beta-lactams reported allergy
研究组 & 干预措施
Critically ill patients with acute brain injury
Patients with severe acute brain injury defined by a Glasgow coma scale < or = 8, admitted to the intensive care unit and needed invasive mechanical ventilation for at least 48 hours.
结局指标
主要结局
Percentage of patients with PK/PD target attainment
时间窗: 24 hours
Proportion of patients with serum concentrations of CEFTRIAXONE above the minimal inhibitory concentration (MIC) of 4 mg/mL (in case of undocumented VAP), or \> 4 times the MIC of documented bacteria.
次要结局
- Impact of the PK/PD target attainment on the incidence of early ventilator associated pneumoniae(Day 7)
- Association between augmented renal clearance and PK/PD target attainment(24 hours)
- Association between hyperbilirubinemia and PK/PD target attainment(24 hours)
- Association between PK/PD target attainment and day 28 mortality(Day 28)
- Association between PK/PD target attainment and ICU length of stay(3 months)
- Incidence of multi drug resistance bacteria(Day 28)
研究者
STEIB Maureen
Assistante Spécialiste
Central Hospital, Nancy, France