Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with Cystic Fibrosis.
详细描述
Recent epidemiological studies have demonstrated that the presence of methicillin-resistant Staphylococcus aureus (MRSA) in the airways of patients with CF is associated with more rapid lung function decline and a higher mortality. Tedizolid is a new antibiotic with potent activity against MRSA. Tedizolid is currently FDA approved for treatment of skin soft tissue infections with MRSA. The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with CF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Diagnosis of CF based on positive sweat chloride or known CF mutation
- •Age > 17 years
- •Able to spontaneously expectorate sputum
排除标准
- •Any clinically significant laboratory abnormalities
- •Presence of an ongoing acute pulmonary exacerbation
- •Pregnancy
- •Serious past allergy to linezolid or tedizolid
- •No alcohol, nicotine, or caffeine-containing products during the study period
研究组 & 干预措施
Tedizolid PO
Tedizolid phophate 200mg tablet
干预措施: Tedizolid PO (Drug)
Tedizolid IV
Tedizolid phophate 200mg IV
干预措施: Tedizolid IV (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 2 days
Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC)
时间窗: 2 days
Area under the curve was calculated using samples collected at baseline (0 h) , 0.5, 1, 2, 3, 4, 8, 24, and 48 hours post-dose and using the equation AUC=Dose\*F/CL
Time to Peak Plasma Concentration (Tmax)
时间窗: 2 days
Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Peak Sputum Concentration
时间窗: 2 days
Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose.
Area Under the Sputum Concentration Versus Time Curve (AUC)
时间窗: 2 days
AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Time to Peak Sputum Concentration (Tmax)
时间窗: 2 days
Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. Tmax was derived from pooled sputum data due to sparse samples and therefore do not have standard deviations.
次要结局
未报告次要终点
研究者
Paul Beringer
Associate Professor
University of Southern California