2023-506734-73-00招募中4 期
Pharmacokinetics study of Cefazolin in haemodialysis (CEFAZODIAL)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Time during which the plasma concentration of cefazolin is greater than the target concentration of 40 mg/L.
研究概览
简要总结
Description of the pharmacokinetics of cefazolin in chronic haemodialysis patients with infections, as part of routine care.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 years or over
- •On chronic intermittent dialysis
- •With a stated indication for initiation of cefazolin either : 1/ For probabilistic treatment of a clinical presentation suggestive of SAMS infection 2/ For treatment of Gram-positive cocci bacteremia
- •With the possibility of taking peripheral blood samples or blood samples from the dialysis machine until the next dialysis session at 48 hours
- •Covered by or entitled to social security
- •Signed informed consent form
排除标准
- •Pregnant or breastfeeding woman
- •Dialysis lasting less than 3 hours, which most often corresponds to "acute" dialysis or the start of chronic dialysis which fundamentally changes the elimination profile
- •Allergy to cephalosporin and penicillin antibiotics (5-10% risk of cross-reactivity)
- •Non-anuric subjects with inhibitors of tubular creatinine secretion: Curative-dose trimethoprim, Cimetidine, Ritonavir, Rilpivirine, Dolutegravir, Cobicistat
- •Patient following any measures of legal presentation
结局指标
主要结局
Time during which the plasma concentration of cefazolin is greater than the target concentration of 40 mg/L.
Time during which the plasma concentration of cefazolin is greater than the target concentration of 40 mg/L.
次要结局
- Occurrence of adverse events (within 6 weeks of last dose)
- Early clinical efficacy (at 1 week from start of treatment) in cefazolin-susceptible patients, defined as freedom from failure, composite endpoint including: 1/ Persistence of fever >38°C 2/ Persistence of positive blood cultures for the same germ(s) 3/ Death for infectious reasons 4/ Change of antibiotic therapy due to ineffectiveness
- Late clinical efficacy (at 6 weeks from the start of treatment) in patients with cefazolin-susceptible organisms, defined as absence of failure, composite criterion including : 1/ Persistence of positive blood cultures 2/ Recurrence of initial infection 3/ Death due to infection 4/ Change of antibiotic therapy due to ineffectiveness
- Each of the criteria of the 2 composite scores taken in isolation
- Association of pharmacokinetic variability factors (covariates) with the occurrence of under- or over-exposure (concentration below 40mg/L or above 80mg/L)
研究者
Coordinating Investigator
Scientific
Centre Hospitalier Regional Universitaire De Tours
研究点 (2)
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