NCT06766461招募中4 期
Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 980
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
The aim of this study is to investigate if an initial short double dose of beta-lactam antibiotics will reduce mortality in critically ill patients with sepsis.
详细描述
Objective
To determine if using higher dosages of beta-lactam antibiotics in the initial phase of sepsis improves clinical outcome of critically ill patients.
Main trial endpoints
The main trial endpoint is all cause 28-day mortality.
Secondary trial endpoints
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
- •≥18 years of age
- •Receiving intravenous antibiotic therapy of the target drugs (including continuous infusion of beta-lactam antibiotics)
- •Primary infection
- •Admitted to the ICU
- •Meeting the Sepsis-3 criteria for septic shock: sepsis in addition to shock requiring the start of vasopressors to maintain a mean arterial pressure 65 mmHg or greater, and a serum lac tate level greater than 2.0 mmol/L following "adequate fluid resuscitation".
排除标准
- •Patient or legal representative not available to give informed consent within 72 hours after admittance
- •Pregnancy
- •Admittance for burn wounds
- •Patients receiving target antibiotics only as prophylaxis within the context of Selective Diges tive tract Decontamination (SDD)
- •Enrolment in another interventional trial
- •Patient received the study antibiotic for more than 24 hours before inclusion
- •Patient receiving extracorporeal membrane oxygenation (ECMO)
- •Patient is already treated with a double dose of antibiotics based on suspected infection
研究组 & 干预措施
Intervention
Experimental
This arm will be treated with double dosages of beta-lactam antibiotics the first 48 hours after inclusion.
干预措施: Double dosing of beta-lactam antibiotic (Drug)
结局指标
主要结局
28-day mortality
时间窗: From enrollment to 28 days
次要结局
- 90-day mortality(From enrollment to 90 days)
- 365-day mortality(From enrollment to the 365 days)
- ICU lengt of stay(From enrollment to the end of the study period at 12 months)
- Hospital lengt of stay(From enrollment to the end of the study period at 12 months)
- Time to shock reversal(From enrollment to the end of the study period at 12 months)
- Microbiological eradication(From enrollment to hospital discharge)
- Clinical cure(From enrollment to 14 days)
- Plasma concentrations of the beta-lactam antibiotics(From enrollment to day 3)
- Delta SOFA(From enrollment to day 3)
- Delta Lactate(From enrollment to day 3)
- Quality of life(3 and 12 months after inclusion)
- Medical consumption(3 and 12 months after inclusion)
- Productivity(3 and 12 months after inclusion)
- Adverse events and toxicity(From enrollment until the end of the study period at 12 months)
研究者
Birgit Koch
Principal Investigator
Erasmus Medical Center
研究点 (1)
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