Antibiotic Concentrations Among Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 13
- 主要终点
- [antibiotics] in blood versus bactericidal activity
研究概览
简要总结
The primary objective of the DALI study is to compare antibiotic concentrations in patient blood samples with bacteriological objectives associated with maximum bactericidal activity. The antibiotics studied are certain lactams and glycopeptides.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •The patient (or his/her "trusted representative") must have given his/her informed and signed consent
- •Antibiotic treatment is administered with beta-lactams or glycopeptides administered continuously or intermittently (Can be of the following: Amoxicillin-clavulanic acid, ampicillin, piperacillin-tazobactam, penicillin G, flucloxacillin, dicloxacillin, cloxacillin, cefazolin, ceftazidime, ceftriaxone, cefepime, meropenem, imipenem, doripenem, ertapenem; Vancomycin, teicoplanin).
- •A vein or artery catheter is established to facilitate blood sampling (arterial catheter is preferred)
排除标准
- •None of the above-mentioned antibiotics are administered
- •Impossible to establish venous or arterial catheter
- •Consent not given
- •Patient is pregnant, parturient or breastfeeding
- •The patient is under tutorship or curatorship
- •The patient is participating in another study
研究组 & 干预措施
Patients
Patients with a vein or artery catheter and who are being administered antibiotics. The latter can be of the following: Amoxicillin-clavulanic acid, ampicillin, piperacillin-tazobactam, penicillin G, flucloxacillin, dicloxacillin, cloxacillin, cefazolin, ceftazidime, ceftriaxone, cefepime, meropenem, imipenem, doripenem, ertapenem; Vancomycin, teicoplanin. (see inclusion/exclusion criteria).
干预措施: Blood sampling (Biological)
结局指标
主要结局
[antibiotics] in blood versus bactericidal activity
时间窗: 30 minutes before second antibiotic dose (expected maximum of 7 days; days 1 to 7)
The primary endpoint for the DALI study is the comparison of antibiotic concentrations in patient blood samples with bacteriological objectives associated with maximum bactericidal activity. The antibiotics studied are certain lactams (endpoint pharmacokinetics 50 and 100% T\> MIC) and glycopeptides (100% T\> 4xCMI and report ASC0-24/CMI ≥ 350).
次要结局
- Apache II score(at time of blood sampling (day 1))
- SOFA score(at time of blood sampling (day 1))
- PIRO score(at time of blood sampling (day 1))
- Diagnosis at admission(Admission to ICU (day 1))
- Indication for antibiotic treatment(at time of blood sampling (day 1))
- did the patient have a surgical procedure in the last 24 hours?(at time of blood sampling (day 1))