Empirical Meropenem Dosing in Critically Ill Patients: Early Assessment of Plasma Exposure and Minimum Inhibitory Concentration Targets
Meropenem Dosing in Critically Ill Patients: Early Evaluation of Plasma Concentrations and Minimum Inhibitory Concentration
The goal of this prospective cohort study is to characterize meropenem exposure in critically ill adult patients receiving empiric antibiotic treatment in the intensive care unit (ICU). Empiric treatment refers to the administration of antibiotics before the causative microorganism and its antimicrobial susceptibility profile are known. In clinical practice, meropenem is commonly administered using different dosing strategies, including 1 g or 2 g doses given as either a 30-minute or a 3-hour infusion. The minimum inhibitory concentration (MIC) is the lowest concentration of an antibiotic required to inhibit bacterial growth and is used as a reference value to evaluate antibiotic exposure. The main questions it aims to answer are:
Do meropenem plasma concentrations differ between patients receiving 1 g and those receiving 2 g, administered as either a 30-minute or a 3-hour infusion during the first 48 hours of empirical treatment in critically ill patients? Does the duration of time above the theoretical MIC of 2 mg/L differ between patients receiving meropenem 1 g and those receiving 2 g, administered as either a 30-minute or a 3-hour infusion during the first 48 hours of empirical treatment in critically ill patients?
Researchers will compare different meropenem dosing regimens (1 g versus 2 g administered as a 30-minute or a 3-hour infusion) to determine which strategy provides a longer duration of plasma concentrations above the theoretical MIC of 2 mg/L.
Participants will:
Receive meropenem as part of their standard clinical care. Have blood samples collected during the first 48 hours of treatment to measure meropenem plasma concentrations.
Have pharmacokinetic/pharmacodynamic parameters evaluated, including the percentage of time that meropenem concentrations remain above the theoretical target MIC.
An exploratory objective of the study is to describe 28-day mortality and intensive care unit length of stay according to meropenem dose group.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Buenos Aires、阿根廷
- Hospital Italiano de Buenos Aires
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults ≥18 years of age.
- Hospitalization in the Intensive Care Unit (ICU), Intermediate Care Unit (ICU step-down/IMCU), or Coronary Care Unit (CCU).
- Receipt of empiric meropenem therapy for at least 24 hours, regardless of the site of infection.
- Written informed consent provided by the patient or their legally authorized representative prior to study participation.
Exclusion Criteria:
- History of severe adverse reactions to meropenem.
- Availability of microbiological identification results prior to blood sampling for meropenem concentration measurement.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Meropenem 1 g
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Blood samples of 5 ml were collected within the interdose interval.
Sample collection times varied among subjects, ensuring coverage of at least one sample every 30 minutes after administration of 1 g or 2 g of meropenem.
After collection, samples were immediately transferred to the laboratory and stored at -80 °C until analysis.
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实验性的:Meropenem 2 g
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Blood samples of 5 ml were collected within the interdose interval.
Sample collection times varied among subjects, ensuring coverage of at least one sample every 30 minutes after administration of 1 g or 2 g of meropenem.
After collection, samples were immediately transferred to the laboratory and stored at -80 °C until analysis.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Percentage of time during the first 48 hours of meropenem therapy that plasma concentrations remain above the theoretical target MIC of 2 mg/L (%T>MIC).
大体时间:During the first 48 hours of empirical treatment
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During the first 48 hours of empirical treatment
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合作者和调查者
出版物和有用的链接
一般刊物
- Dulhunty JM, Roberts JA, Davis JS, Webb SA, Bellomo R, Gomersall C, Shirwadkar C, Eastwood GM, Myburgh J, Paterson DL, Lipman J. Continuous infusion of beta-lactam antibiotics in severe sepsis: a multicenter double-blind, randomized controlled trial. Clin Infect Dis. 2013 Jan;56(2):236-44. doi: 10.1093/cid/cis856. Epub 2012 Oct 16.
- O'Jeanson A, Larcher R, Le Souder C, Djebli N, Khier S. Population Pharmacokinetics and Pharmacodynamics of Meropenem in Critically Ill Patients: How to Achieve Best Dosage Regimen According to the Clinical Situation. Eur J Drug Metab Pharmacokinet. 2021 Sep;46(5):695-705. doi: 10.1007/s13318-021-00709-w. Epub 2021 Aug 17.
- Zhao HY, Gu J, Lyu J, Liu D, Wang YT, Liu F, Zhu FX, An YZ. Pharmacokinetic and Pharmacodynamic Efficacies of Continuous versus Intermittent Administration of Meropenem in Patients with Severe Sepsis and Septic Shock: A Prospective Randomized Pilot Study. Chin Med J (Engl). 2017 May 20;130(10):1139-1145. doi: 10.4103/0366-6999.205859.
- Kothekar AT, Divatia JV, Myatra SN, Patil A, Nookala Krishnamurthy M, Maheshwarappa HM, Siddiqui SS, Gurjar M, Biswas S, Gota V. Clinical pharmacokinetics of 3-h extended infusion of meropenem in adult patients with severe sepsis and septic shock: implications for empirical therapy against Gram-negative bacteria. Ann Intensive Care. 2020 Jan 10;10(1):4. doi: 10.1186/s13613-019-0622-8.
- Mehrotra R, De Gaudio R, Palazzo M. Antibiotic pharmacokinetic and pharmacodynamic considerations in critical illness. Intensive Care Med. 2004 Dec;30(12):2145-56. doi: 10.1007/s00134-004-2428-9. Epub 2004 Nov 5.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 7038
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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