Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Target concentrations.
研究概览
简要总结
The study investigates whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI) of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Have a positive blood culture.
- •Undergo treatment with either intravenous penicillin, ampicillin, piperacillin/tazobactam, dicloxacillin, cefuroxime or meropenem.
- •Hospitalised at Hvidovre University Hospital.
- •Able to understand and give informed consent.
- •Included in the study within 24 hours after the final positive blood culture answer.
排除标准
- •Positive blood culture is interpreted as contamination.
- •The patient dies before the intervention.
研究组 & 干预措施
TDM and CI.
Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.
干预措施: Continuous infusion of beta-lactam antibiotics . (Drug)
TDM and CI.
Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.
干预措施: Therapeutic drug monitoring of beta-lactam antibiotics. (Other)
结局指标
主要结局
Target concentrations.
时间窗: 30 days after intervention.
Serum concentrations within the target values for intervention. Following beta-lactams is included in the study: Benzylpenicillin, ampicillin, dicloxacillin, piperacillin/tazobactam, cefuroxime and meropenem.
次要结局
- Morbidity.(30 days after intervention.)
- Number of days until medically discharged.(30 days after intervention.)
- Failed antibiotic treatments.(30 days after intervention.)
- Amount of antibiotic used.(30 days after intervention.)
- Antibiotic side effects and complications.(30 days after intervention.)
- Mortality.(30 days after intervention.)
- Number of participants with abnormal clinical data and/or abnormal laboratory values.(30 days after intervention.)
研究者
Sara Thønnings
MD
Hvidovre University Hospital