2024-519783-41-00招募中2 期
Early optimization of ceftazidine dosing regimen in critical care : FORTOPTIM_1
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Percentage of subjects with a ceftazidime concentration equal to or above the target concentration threshold (35 mg/L) at both 3h and 24h after the first administration and below the toxicity threshold of 100 mg/L
研究概览
简要总结
to evaluate a ceftazidime regimen optimized for rapid attainment and maintenance of target concentration in the critical care patient versus the standard regimen.
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
- •Patient at least 18 years old
- •Patient hospitalized in critical care for an expected duration of at least 72 hours, with an infection for which initiation of ceftazidime therapy is being considered
- •Patient with arterial catheter for blood sampling
- •Patient affiliated to or entitled under a social security scheme
排除标准
- •Pregnant, parturient and nursing women
- •Person deprived of liberty, hospitalized without consent
- •Adult subject to a legal protection measure (guardianship-curatorship)
- •History of severe hypersensitivity to ceftazidime, other cephalosporins or any other type of beta-lactam
- •Patients who have received ceftazidime within the last 72 hours
- •Patients undergoing renal replacement therapy or whose CKD-EPI at the start of treatment is less than 15 ml/min
结局指标
主要结局
Percentage of subjects with a ceftazidime concentration equal to or above the target concentration threshold (35 mg/L) at both 3h and 24h after the first administration and below the toxicity threshold of 100 mg/L
Percentage of subjects with a ceftazidime concentration equal to or above the target concentration threshold (35 mg/L) at both 3h and 24h after the first administration and below the toxicity threshold of 100 mg/L
次要结局
- Death up to D28
- Patient severity assessed using the SOFA (Sepsis related Organ Failure Assessment) score at D0 and D7. The SOFA score is a tool used in intensive care to assess the severity of organ failure in critical patients. The score assesses the function of six systems: respiratory, cardiovascular, hepatic, hemostatic, renal and neurological. Each system is scored from 0 to 4, meaning that the total SOFA score can vary from 0 to 24. There is no specific threshold for determining disease severity, as the S
- Occurrence of neurological adverse events defined as: seizure, myoclonus, encephalopathy or delirium, altered consciousness (Glasgow score)
- Occurrence of an overdose defined as a concentration greater than 100 mg/L
- Renal function assessed using the following estimators: creatinemia cystatin CKD-EPI, creatinuria/creatininemia ratio (U×V/P) and eGFR creat-cystatin
- Time to reach PK/PD targets (in hours post treatment introduction)
研究者
Project manager
Scientific
Centre Hospitalier Universitaire De Saint Etienne
研究点 (4)
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