Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of imipenem and relebactam
研究概览
简要总结
This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years of age
- •Admitted to the ICU
- •BMI ≥40 kg/m2 and/or total body weight ≥120 kg
- •Provide a signed and dated written informed consent prior to study participation
排除标准
- •History of significant hypersensitivity reaction or intolerance to imipenem/cilastatin or carbapenem-based agents (doripenem, ertapenem, or meropenem +/- vaborbactam)
- •History of seizures and/or receiving 1 or more anti-epileptic agent
- •Serum creatinine ≥1.5 mg/dL
- •Estimated creatinine clearance (CLCR) <60 mL/minute as determined by Cockcroft-Gault equation:
- •Actively receiving antimicrobial therapy for treatment of a confirmed or suspected infection
- •The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days prior to the first dose of study medication
- •Positive serum pregnancy test (for women of childbearing potential)
- •Currently breast feeding
- •Has previously participated in this study
- •Concomitant use of valproic acid or divalproex sodium
- •Any other condition that may make the patient unsuitable for the study in the judgement of the investigator
研究组 & 干预措施
Pharmacokinetic cohort
After at least 2 doses of study drug, serial blood samples will be collected from 12 non-infected, obese ICU patients to evaluate the pharmacokinetics of imipenem and relebactam in this population.
干预措施: Imipenem/Cilastatin/Relebactam 1.25g (Drug)
Safety cohort
After at least 2 doses of study drug, safety will be monitored closely during study drug dosing and through 72 hours after the last dose is administered in the same 12 non-infected, obese ICU patients from the PK arm
干预措施: Imipenem/Cilastatin/Relebactam 1.25g (Drug)
结局指标
主要结局
Pharmacokinetic parameters of imipenem and relebactam
时间窗: 6 months
Apparent volume of distribution (Vd)
次要结局
- Safety of imipenem and relebactam(6 months)