A Prospective, Open-Label, Randomized Controlled, Multicenter Clinical Study on Continuous vs. Intermittent Infusion of Ceftazidime-Avibactam in Critically Ill Patients With Severe Infections
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 主要终点
- 90-day all cause mortality
研究概览
简要总结
The objective of this study is to determine whether continuous infusion of ceftazidime-avibactam (CAZ-AVI) could improve clinical outcomes in critically ill patients compared with intermittent infusion.
详细描述
This study employs a prospective, open-label, randomized controlled, multicenter clinical trial design comparing "CAZ-AVI continuous infusion" versus "CAZ-AVI intermittent infusion," .The secondary objectives is to observe the clinical cure, Bacterial clearance, the probability of target attainment (PTA) of TDM. etc
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 years old, male or female.
- •Patients who are admitted to ICU wards.
- •Patients clinically diagnosed with carbapenem-resistant organism (CRO) infections, and has been commenced on targeted therapy with ceftazidime-avibactam.
- •One or more organ dysfunction criteria in the previous 24 hours i. MAP < 60 mmHg for at least 1 hour; ii. Vasopressors required for > 4 hours; iii. Respiratory support using supplemental high flow nasal prongs, continuous positive airway pressure, bilevel positive airway pressure or invasive mechanical ventilation for at least 1 hour.
- •iv. Serum creatinine concentration > 220 μmol/L or >2.49 mg/dL
排除标准
- •Patient has a known allergy to ceftazidime-avibactam.
- •Patient has received ceftazidime-avibactam for more than 48 hours during current infectious episode.
- •Patient is in severe condition or expected to survive for no more than 48 hours.
- •Patient who receives lung or heart transplant or stem cell transplant.
- •Patient is known or suspected to be pregnant.
- •Patient has previously been enrolled in the current study.
- •Other conditions which are regarded as inappropriate for enrollment.
研究组 & 干预措施
the intermittent infusion group
Ceftazidime-avibactam will be administered as 2.5 g q8h by intermittent infusion for 2 h, and the dosage could be adjusted according to the instructions.
干预措施: treatment with CAZ-AVI (Drug)
the continuous infusion group
After a loading dose of ceftazidime-avibactam, continuous infusion is administered, with the dose adjustment rules consistent with those of the intermittent infusion group.
干预措施: treatment with CAZ-AVI (Drug)
结局指标
主要结局
90-day all cause mortality
时间窗: from randomization to day 90
the proportion of subjects who die within 90 days after randomization to the number of subjects in each group
次要结局
未报告次要终点
研究者
Jianfeng Xie
director
Southeast University, China