2022-502013-28-00招募中4 期
STRAtified Dosing based on Augmented renal clearance for CEFtriaxone in patients with severe community-acquired pneumonia: the STRADA-CEF trial
UZ Leuven, UZ Leuven6 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2023年12月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 6
- 主要终点
- Intensive care unit (ICU) Length of Stay (LOS)
研究概览
简要总结
The general objective of this project is to evaluate the clinical benefit and safety of stratified every 24-hour (q24h) vs. q12h 2g ceftriaxone therapy in critically ill patients with sCAP based on the risk for development of ARC.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Intensive care unit (ICU) Length of Stay (LOS)
Intensive care unit (ICU) Length of Stay (LOS)
次要结局
- Delta SOFA score
- ICU mortality
- 28-day mortality
- Hospital LOS
- Alive ICU free days at day 28
- Ventilator-free days at day 28
- Clinical cure at day 14
- Microbial eradication at day 14
- Emergence of resistance at day 14
- PK/PD target attainment
- Assessment of safety
- Procalcitonin and C-reactive protein concentrations
研究者
Matthias Gijsen
Scientific
UZ Leuven
研究点 (6)
Loading locations...
相似试验
已完成
1 期
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859HealthyNCT02766621Pfizer62
已完成
1 期
Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASHNon-alcoholic SteatohepatitisNCT04202354Arrowhead Pharmaceuticals50
已完成
1 期
A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis CChronic Hepatitis C InfectionGenotype 1NCT01194037HanAll BioPharma Co., Ltd.30
已完成
1 期
Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy VolunteersHealthy Volunteer StudyNCT02393950Orion Corporation, Orion Pharma16
已完成
1 期
A Phase I Clinical Trial of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque PsoriasisNCT07051538Guangdong Hengrui Pharmaceutical Co., Ltd64