Comparison of Lung Concentrations of Ceftazidime Administered by Continuous Versus Intermittent Infusion in Patients With Ventilator-associated Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- lung tissue concentration of ceftazidime
研究概览
简要总结
Ceftazidime is a beta-lactam compound that exerts a time-dependent bactericidal effect. Numerous arguments are in favor of continuous administration of ceftazidime, both for reasons of clinical efficacy and to preserve bacteriological mutation. The investigators report a prospective, single-center, parallel-group, randomized, controlled trial comparing two modes of administration of ceftazidime, namely, continuous administration (loading dose of 20 mg/kg of body weight followed by 60 mg/kg/day) versus intermittent administration (20 mg/kg over 30 min every 8 h) in 34 patients with ventilator-associated pneumonia due to Gram-negative bacilli. The study was performed over 48 h with 13 and 18 assessments of serum ceftazidime in the continuous-infusion group (group A) and the intermittent-fusion group (group B), respectively. Bronchoalveolar lavage (BAL) was performed at steady state in both groups at 44 h to determine ceftazidime levels in the epithelial lining fluid. The investigators chose a predefined threshold of 20 mg/liter for serum concentrations of ceftazidime because of ecological conditions in our center.
详细描述
Primary objective
The main objective of this study is to show the continuous administration of superiority ceftazidime versus intermittent administration, in terms of lung tissue concentration of ceftazidime in mechanically ventilated patients with pneumonia caused by a bacillus gram negative.
Methods
Trial
Prospective therapeutic trial in parallel groups, controlled, randomized, single center comparing two methods of administration of ceftazidime (continuous administration by self-pulsed syringe versus discontinuous administration regimens to 3 injections per 24 hours) in patients with severe pneumonia in mechanically ventilated due to gram negative bacillus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- •Weight >110 kg;
- •Pregnant or breastfeeding women;
- •Known allergy to beta - lactam antibiotics;
- •Renal impairment: clearance <60 calculated by the Cockcroft and Gault;
- •Known history of pulmonary fibrosis;
- •Patients included in another research protocol.
研究组 & 干预措施
continuous administration of ceftazidime
干预措施: ceftazidime (Drug)
intermittent administration of ceftazidime
干预措施: ceftazidime (Drug)
结局指标
主要结局
lung tissue concentration of ceftazidime
时间窗: up to 44 hours
次要结局
未报告次要终点
