Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 30
- 主要终点
- Change in forced expiratory volume in 1s (FEV1) between the beginning and the end of the IV antibiotic course, expressed as a percentage of the predicted normal value
研究概览
简要总结
The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.
详细描述
Each patient received two successive IV antibiotic courses during a period of pulmonary exacerbation. One of these courses was delivered as thrice daily 30-minute infusions of ceftazidime in 100 ml of 0.9% sodium chloride, and the other was delivered as a continuous infusion of ceftazidime in 230 ml of 0.9% sodium chloride, over 23 hours. The daily dose of ceftazidime was 200 mg/kg, with a maximum dose of 12 g. For ceftazidime continuous infusion, a loading dose of 60 mg/kg (maximum 2 g) was used. All patients also received tobramycin (10 mg/kg), in the form of one 30-minute infusion per day. Portable devices were used: Intermate® SV 200 (Baxter) for the 30-minute short infusions of ceftazidime and tobramycin, Infusor® LV10 (Baxter) for continuous infusion of ceftazidime.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with cystic fibrosis older than 8 years
- •with chronic Pseudomonas aeruginosa infection of the respiratory tract
- •with at least 2 courses of IV antibiotic in the year before enrolment
- •at the time of a pulmonary exacerbation
排除标准
- •allergy to ceftazidime or tobramycin
- •bronchial colonization with Burkholderia cepacia
- •renal impairment
- •history of lung transplantation
结局指标
主要结局
Change in forced expiratory volume in 1s (FEV1) between the beginning and the end of the IV antibiotic course, expressed as a percentage of the predicted normal value
次要结局
- the interval between 2 successive IV antibiotic courses
- quality of life scores
- sputum collected at the beginning and the end of each antibiotic course
- plasma ceftazidime concentration at steady state (Css) for ceftazidime continuous infusion, and before (C trough), 30 minutes (Cmax) and 4 hours after (C4) the beginning of ceftazidime short infusion
- C-reactive protein, leukocytes and hepatic enzymes levels at the beginning and the end of each IV antibiotic course