Continuous Infusion Versus Intermittent Administration of Linezolid - Impact on Clinical Outcome and Adverse Reactions in Critically Ill Patients: a Pharmacokinetic and Pharmacodynamic Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Linezolid plasmatic concentrations
研究概览
简要总结
The purpose of this study is to evaluate the therapeutic efficacy expressed in pharmacokinetic/pharmacodynamic (PK/PD) indices, the clinical response and the risk of adverse reactions following the continuous and intermittent administration of linezolid in critical patients in the Intensive Care Unit.
Subject inclusion criteria:
A minimum of 30 subjects in each group will be included in the study, in accordance with the study inclusion criteria:
- patients hospitalized in the intensive care unit,
- female or male sex,
- age over 18 years,
- linezolid is prescribed by the attending physician, in empirical or targeted treatment
Exclusion criteria:
Patients who have documented severe liver failure (Child-Pugh C score). Patients who refuse to sign the informed consent
详细描述
The clinical study will be conducted in accordance with the protocol approved by the Ethics Commission of the "I.Haţieganu" University of Medicine and Pharmacy and the Ethics Commission of the Municipal Clinical Hospital, from Cluj-Napoca, in accordance with the rules of good clinical study practice.
The study will take place on the Intensive Care Unit of University Clinical Municipal Hospital from Cluj-Napoca, Romania. The analysis of blood drug concentration will be carried out at University of Medicine and Pharmacy 'Iuliu Hatieganu', Pharmacokinetics and Biopharmacy Laboratory, from Cluj-Napoca, Romania.
The objectives of the study are:
- Determination and the comparison of the pharmacokinetic and pharmacodynamic parameters of linezolid administration following intermittent infusion or continuous infusion, in critically ill patients.
- Determination of the minimum inhibitory concentrations (MIC) for linezolid for the identified bacteria (Staphylococcus aureus, Coagulase-Negative Staphylococcus, Enterococcus spp., Streptococcus pneumoniae).
The study will be conducted in the ICU Department of the Municipal Clinical Hospital in Cluj-Napoca, Romania, following an open, prospective, randomized design, with two groups of patients (group with intermittent infusion and group with continuous infusion of the same daily dose of linezolid). The patients that will be included in each group will be the patients in need of intensive care who are prescribed linezolid by the attending physician, as empirical or targeted therapy.
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
- None
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
- •patients hospitalized in the intensive care unit,
- •female or male sex,
- •age over 18 years,
- •linezolid is prescribed by the attending physician, in empirical treatment or based on the antibiogram.
排除标准
- •documented severe liver failure (Child-Pugh C).
- •no informed consent signed
结局指标
主要结局
Linezolid plasmatic concentrations
时间窗: first 2-14 days (during treatment)
10 plasmatic concentrations in the first 48h of linezolid treatment, then 1 plasmatic concentration per day until the end of the treatment
次要结局
- Linezolid adverse reactions(from day 1 to day 30 after therapy initiation)
- Linezolid clinical efficacy(from day 1 to day 30 after therapy initiation)
研究者
Bodolea Constantin
Assoc Prof. Dr.
Cluj Municipal Clinical Hospital