The ROAD Study - Resistant Optimised Antimicrobial Dosing in Critically Ill Patients - Pharmacokinetic/pharmacodynamic–optimised beta-lactam dosing to prevent the emergence of bacterial resistance: a proof-of-concept

Reduce Centre of Research Excellence - University of Queensland0 个研究点目标入组 24 人2020年6月10日

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Reduce Centre of Research Excellence - University of Queensland
入组人数: 24
状态: 尚未招募
最后更新: 5年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2020年6月10日

结束日期

待定

最后更新

5年前

研究类型

Interventional

性别

All

研究者

发起方

Reduce Centre of Research Excellence - University of Queensland

入排标准

入选标准

•1\.Adult (\>18 years old) ICU patient
•2\.Confirmed or strong suspicion of infection during current ICU admission
•3\.Patient has been prescribed or is receiving either meropenem or piperacillin/tazobactam for the treatment of current infection
•4\.Patient is expected to complete at least a 5\-day course of meropenem or piperacillin/tazobactam therapy in the ICU
•5\.Patient has either an arterial line or central venous catheter for blood sampling
•6\.Informed consent to participate in the study

排除标准

•1\.Patient with a non\-complicated urinary tract infection during current ICU admission
•2\.Suspected or known hypersensitivity towards beta\-lactam antibiotics (pre– or post\-enrolment)
•3\.Patient has received study antibiotic for more than 48 hours during current infective episode
•4\.Patient has any of the following parameters:
•estimated creatinine clearance \<15 mL/min OR plasma creatinine concentration \>200 µmol/L OR receiving renal replacement therapy (RRT)
•alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) \>3 x the upper limit of the normal reference range
•alkaline phosphatase (ALP) \>3 x the upper limit of the normal reference range
•total bilirubin \>2 x the upper limit of the normal reference range
•haematocrit \<21% or haemoglobin \<70 g/L
•neutropenia with absolute neutrophil count \<500/mm3

结局指标

主要结局

未指定

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