Empirical Meropenem versus Piperacillin/Tazobactam for Adult Patients with Sepsis (EMPRESS) trial

Rigshospitalet0 个研究点目标入组 400 人开始时间: 2023年12月20日最近更新: 2024年8月21日

适应症

试验速览

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•Age = 18 years, Sepsis (including septic shock) defined according to the Sepsis-3 criteria, i.e., suspected or documented infection and an acute increase of = 2 points in the Sequential Organ Failure Assessment (SOFA) score (a marker of acute organ dysfunction), Critical illness defined as use of at least one of the following: a.Invasive mechanical ventilation b. Non-invasive ventilation c. Continuous use of continuous positive airway pressure (CPAP) for hypoxia d. Oxygen supplementation with an oxygen flow of = 10 litres (L)/minute independent of delivery system and total flows e. Continuous infusion of any vasopressor or inotrope (excluding strictly procedure-related infusions), Clinical indication for empirical treatment with either meropenem or piperacillin/tazobactam

•Preceding intravenous treatment with meropenem or piperacillin/tazobactam for > 24 hours prior to screening, Patient under coercive measures, Fertile women < 60 years of age with known pregnancy or positive urine human gonadotropin (hCG) or plasma hCG, Known hypersensitivity or allergy to beta-lactam antibiotics, Suspected or documented central nervous system infection, Known infection/colonialization with microorganism with acquired resistance against meropenem or piperacillin/tazobactam within the previous 3 months (e.g., ESBL-, AmpC- or carbapenemase-producing bacteria), Current or planned use of valproate within 30 days from randomisation, Patient included in another interventional trial where co-enrolment with EMPRESS is not permitted, Previously randomised into the EMPRESS trial, Informed consent following inclusion expected to be unobtainable

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