STRAtified Dosing based on Augmented renal clearance for CEFtriaxone in patients with severe community-acquired pneumonia: the STRADA-CEF trial

Z Leuven0 个研究点目标入组 270 人开始时间: 2023年9月20日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to – or within 72 hours after oral consent prior to – any screening procedures, Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner., Aged 18 years or older at the baseline visit, Confirmed diagnosis of sCAP, as defined by the current IDSA/ATS guideline, Ceftriaxone initiated for sCAP, (Planned) admission to an ICU ward

•Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol, Need for renal replacement therapy on the day of inclusion, Ceftriaxone treatment >12h before study enrolment, Patients with (suspicion of) meningitis, requiring treatment with ceftriaxone 2g q12h, Known hypersensitivity to beta-lactam antibiotics, Patients having received more than 1 amoxicillin-clavulanate dose since hospital admission, Patients expected to be discharged from the ICU within 48h, Patients expected to stop ceftriaxone therapy within 48h, Patients receiving palliative treatment under a discontinue therapy code, Previous enrolment in this study, Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial, Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive. A woman is considered of child-bearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause., Participation in an interventional Trial with an investigational medicinal product (IMP) or device, Mildly to moderately decreased eGFRCKD-EPI (<80 mL/min/1.73m²) at baseline (max. 1 year prior to hospital admission)

发起方

Z Leuven