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 人开始时间: 2020年6月10日最近更新: 2020年6月29日

试验速览

暂无简介。

•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

•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
•platelet count <50000/mm3 from rectal and nasal swabs.
•5.Receiving extracorporeal membrane oxygenation (ECMO)
•6.Pregnant patients or lactating mothers

发起方

Reduce Centre of Research Excellence - University of Queensland