Pharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- concentration of sulbactam in plasma
研究概览
简要总结
Acinetobacter species have emerged as agents of serious nosocomial infections in critically ill patients. Only a few effective antibiotics are currently available for the treatment of this pathogen and, therefore, sulbactam is being considered as an alternative treatment option. The aims of this study were to i) reveal the population pharmacokinetics and ii) assess the probability of target attainment (PTA) of sulbactam in septic critically ill patients caused by Acinetobacter spp. infections.
The study was conducted in septic critically ill patients caused by Acinetobacter spp. Each patient received 2 g every 12 h of sulbactam for 10 days, after which PK studies were carried out on day 4 of sulbactam therapy and a Monte Carlo simulation was performed to determine the probability of attaining a specific pharmacodynamic target.
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
- •Patient aged ≥ 18 years
- •Patients who had diagnosed an Acinetobacter infections that sensitive to sulbactam and colistin
- •Infected at sterile site
- •Pneumonia was defined by a new and persistent infiltrate on chest radiography associated with at least one of the following: purulent sputum, temperature>38.3°C or <36°C, a leukocyte count>10,000 cell per mm3, heart rate of >90 beats per min and respiratory rate >20 breaths per min
- •Urinary tract infection: Acinetobacter spp ≥ 100,000 cfu/mm3
排除标准
- •Patients who are pregnant.
- •Patients who have documented hypersensitivity to sulbactam and colistin
- •Patients who are chronic renal disease
- •Patients who are shock
研究组 & 干预措施
2 g q12 of sulbactam, 1 h infusion
2 g of sulbactam in 100 ml of normal saline solution was administered via an infusion pump at a constant flow rate 1 h every 12 h.
干预措施: Sulbactam (Drug)
结局指标
主要结局
concentration of sulbactam in plasma
时间窗: 12 h profile after 7th of sulbactam
次要结局
未报告次要终点
研究者
Sutep Jaruratanasirikul
Prince of Songkla Univeersity
Prince of Songkla University