2024-516447-12-00招募中4 期
Early Model-Informed Precision Dosing of beta-lactam antibiotics in critically ill children: big solution for small people?
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Proportion of subjects reaching the therapeutic target 100% fT>MIC at 48 hours after start of beta-lactam treatment
研究概览
简要总结
To investigate the impact of early MIPD-guided dosing on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children.
研究设计
- 分配方式
- Randomized
- 主要目的
- Fixed dosing regimens vs. dosing regimens based on prediction by MIPD calculator
- 盲法
- Single (Subject, Analyst)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Subject aged between 0 - 17 years 10 months
- •Subject admitted to a participating ward unit (NICU, PICU, PHO unit)
- •Strongly suspected or confirmed systemic infection
- •Subject planned to start on intravenous amoxicillin-clavulanic acid, piperacillin-tazobactam or meropenem treatment at least aimed for a minimum duration of two days at time of inclusion. If the subject was previously treated with the same beta-lactam, the minimum interval to the previous beta-lactam treatment episode is 40 hours for amoxicillin-clavulanic acid (based on elimination half-life) and 8 hours for piperacillin-tazobactam and meropenem (based on elimination half-life)
- •Informed consent/assent signed by parents or legal representatives of the subject.
- •Not previously enrolled in this trial
排除标准
- •Subject with serum creatinine level ≥ 2 mg/L at inclusion.
- •Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique
- •Subject receiving (or planned to receive) body cooling
- •Subject death is deemed imminent and inevitable
- •Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours after start treatment
- •The subject is known or suspected to be pregnant
- •The subject has a known allergy to the specific beta-lactam antibiotic
结局指标
主要结局
Proportion of subjects reaching the therapeutic target 100% fT>MIC at 48 hours after start of beta-lactam treatment
Proportion of subjects reaching the therapeutic target 100% fT>MIC at 48 hours after start of beta-lactam treatment
次要结局
- Proportion of subjects reaching the therapeutic target 100% fT>MIC at 120 hours after start of treatment
- Proportion of subjects reaching the therapeutic target 100% fT>MIC within the interval 48 to 72 hours after start of treatment
- Hospital length-of-stay
研究者
Prof. Dr. Pieter De Cock
Scientific
Universitair Ziekenhuis Gent
研究点 (1)
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