Efficacy and Safety of Continuous Infusion of Linezolid Compared With Intermittent Dosing in Critically Ill Pneumonic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group
研究概览
简要总结
The investigator's goal in this study is to determine the clinical efficacy and safety of continuous infusion in comparison with standard intermittent infusion.
详细描述
Prospective randomized controlled clinical trial on critically ill Pneumonic patients, included two groups, over one year period. The first group will be administered intravenous (IV) linezolid 600mg twice daily. The second group will be prescribed linezolid (IV) 600 mg loading dose followed by 1200 mg by continuous infusion. Both groups will be co-administered intravenous (IV) Meropenem 1g every 8 hours empirically.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to ICUs diagnosed as HAP or VAP
- •Chest X-ray/ computed tomography showing new or progressive infiltrate.
- •New onset of purulent sputum or change in sputum character.
- •Body temperature greater than 38 ℃ or less than 35.5℃.
- •White blood cell counts greater than 10000 /mm3 or less than 4000 /mm
- •Significant quantitative pathogen cultures from respiratory secretions.
排除标准
- •Age <18 years, Pregnancy, Lactation
- •Previous known allergic reaction to linezolid
- •Creatinine Clearance (CrCl) <10 mL/min, calculated according to the Cockcroft-Gault formula
- •Thrombocytopenia (platelet count less than 80,000/mm3)
- •Severe hepatic failure (Child-Pugh C)
- •Concomitant treatment with other drugs that can potentially interfere with Linezolid (i.e., macrolides, serotonin modulators, omeprazole)
- •Acute DIC score > 4 points or hematological disorder
- •Concurrent drug-associated Thrombocytopenia
研究组 & 干预措施
Continuous infusion
Patients will be received linezolid 600 mg intravenous Loading dose over 30 to 60 minutes followed by 1200 mg/ day by Continuous infusion (50 mg /hr)
干预措施: Continuous infusion Linezolid (Drug)
Intermittent dosing
Patients will be received Linezolid 600 mg intravenous twice daily over 30 to 60 minutes
干预措施: intermittent dosing linezolid (Drug)
结局指标
主要结局
Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group
时间窗: through study completion, over one year
The primary efficacy endpoint will be evaluated as clinical cure on day 7 of Linezolid initiation. Clinical cure defined by normalized body temperature, TLC less than 10,000/mL, absence of purulent secretions, and improvement of radiological findings (x-ray), in addition to Pao2/Fio2 greater than 250 in patients.
Percentage of occurrence of anemia and thrombocytopenia
时间窗: through study completion, over one year
The patients' hematological parameters (hemoglobin (Hb), hematocrit (Hct), and platelets (PLTs) counts) will be compared every 2 days during linezolid treatment between two groups. Anemia is defined as decrease in hemoglobin level \<10 g/dl and Thrombocytopenia is defined as decrese in platelets count \<100 × 103/mm3
次要结局
未报告次要终点
研究者
Ahmed Essam
Principle Investigator
October 6 University