Systemic Exposure to Anti-infectives in Critical Care Units and the Role of Therapeutic Drug Monitoring in Improving Clinical Outcome
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- To compare clinical outcome at day 7 of antibiotic administration between patients who were dose optimized based on TDM reports for antibiotics and those who were not dose optimized based on TDM reports.
研究概览
简要总结
Hypothesis:
The real time therapeutic drug monitoring (TDM) leads to better clinical outcomes and reduced toxicity in critically ill patients compared to dose adjustments performed according to clinician’s discretion.
Purpose:
This interventional study will be performed to evaluate the clinical utility of real time TDM in optimizing anti-infective dosing and improving outcomes in ICU patients.
Study method:
In Phase A, we will recruit 121 critically ill patients based on the study selection criteria and will provide standard care dose adjustments based on clinicians discretion, without any TDM intervention. We will collect trough and Cmax blood samples for evaluation of antibiotic target achievement for evaluation at the end of phase A patient recruitment.
In Phase B, we will recruit 121 critically ill patients based on the study selection criteria and will perform dose optimization based on TDM reports on day 2 or 3, day 4 or 5 and day 6 or 7 and will assess clinical outcome in day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients initiated on any one of the following antibiotics: meropenem, piperacillin, cefoperazone, ceftazidime, amikacin, gentamicin, colistin, polymyxin B, teicoplanin, vancomycin and linezolid.
排除标准
- •Phase A and B Patients who will be lost to follow up within 7 days after initiating one of the above-mentioned antibiotics.
- •Cessation of antibiotic before first sample collection for estimation of drug concentration.
- •Patients without an arterial line on the first day of sample collection Patient continuing on empirical antibiotic without culture proven bacterial infection for 7 days.
- •Phase B When the advice from TDM team for dose optimization is not followed in the initial 5 days of antibiotic dosing.
结局指标
主要结局
To compare clinical outcome at day 7 of antibiotic administration between patients who were dose optimized based on TDM reports for antibiotics and those who were not dose optimized based on TDM reports.
时间窗: Day 7 of antibiotic treatment
次要结局
- To study the systemic exposure to the antibiotics meropenem, piperacillin, cefoperazone, ceftazidime, amikacin, gentamicin, colistin, polymyxin B, teicoplanin, vancomycin and linezolid among the patients who receive these antibiotics on day 2/3, day 4/5 and day 6/7 from the initiation of antibiotic treatment(Day 2 or 3, day 4 or 5 and day 6 or 7 of antibiotic treatment)
- To compare the proportion of patients who develop acute kidney injury or neurotoxicity at day 7 of antibiotic administration between patients who were dose optimized based on TDM reports for antibiotics and those who were not dose optimized based on TDM reports.(Day 7 of antibiotic treatment)
研究者
Philip Mathew
Believers Church Medical College Hospital