Steady-state Pharmacokinetics of Ceftazidime/Avibactam in CF
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Peak Sputum Concentration
研究概览
简要总结
The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.
详细描述
Cystic fibrosis is a genetic disorder characterized by a chronic cycle of airway infection, obstruction, and inflammation leading to progressive loss of lung function and eventual respiratory failure. The principal pathogen is Pseudomonas aeruginosa which is present in the airways of 70% of adult patients with CF. Of particular concern is the increasing resistance observed to existing agents.
While ceftazidime has been the mainstay of treatment for many years, its efficacy is limited by reduced susceptibility. Ceftazidime/avibactam offers a potential advancement in the management of infections involving P. aeruginosa in CF due to its excellent activity, penetration into pulmonary secretions, and reduced potential for development of resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Diagnosis of CF based on positive sweat chloride or know CF mutation
- •Age > 17 years
- •Able to spontaneously expectorate sputum
排除标准
- •Any clinically significant laboratory abnormality
- •Presence of an ongoing acute pulmonary exacerbation
- •Pregnancy
- •Serious past allergy to a beta-lactam antibiotic
研究组 & 干预措施
IV Ceftazidime/Avibactam
Ceftazidime/avibactam 2.5gm IV q8h for 3 doses
干预措施: Ceftazidime/avibactam (Drug)
结局指标
主要结局
Peak Sputum Concentration
时间窗: 8 hours
Peak Plasma Concentration (Cmax)
时间窗: 8 hours
次要结局
未报告次要终点
研究者
Paul Beringer
Associate Professor
University of Southern California