NCT02328183Unknown4 期
Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- mortality rate
研究概览
简要总结
The objective of the study is to evaluate the efficacy of Polymyxin B for treatment Gram negative bacterial infection. The hypothesis of study is Polymyxin B would be the new antibacterial agents for Thai Gram negative infected patients in case of desirable outcomes and minimal side effects.
详细描述
- Investigator is notified by doctors who take care of gram negative infected patients.
- Investigator inform patient or their relatives about all topics in project, eligible criteria, method, material and monitoring treatment.
- After patient or their relatives are appreciated to join this project, investigator collect data in case record form;electronics form, then implement the drug.
- Duration of treatment is determined by site and severity of infection, approximately 7-14 days.
- Sample size calculation, by prevalence formula, we estimate the mortality rate about 50 %, deviation 10 %,and 2-sided 95% Confidence interval, therefore,97 persons
- We estimate gather data about 100 persons.
- Statistical descriptive analysis for descriptive data.
- During the study is performing, all unexpected adverse event definitely report to Siriraj institutional Review Board immediately, in addition to subjects or their relatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 year-old
- •The infection caused by carbapenem-resistant (CR) Enterobacteriaceae, CR P.aeruginosa or CR A. baumannii which susceptible to colistin
- •The duration of treatment approximately between 7-14 days
- •Kidney function, according to Kidney Disease Improving Global Outcomes (KDIGO) classification, should less than stage 4 and no replacement therapy in all modality.
- •The patients are anticipated to live more than 48 hrs after participation.
- •In case of Colistin administration beforehand, it should not exceed 24 hrs.
- •All of participants should be willing to join this project.
排除标准
- •Pregnancy and lactation
- •End stage renal disease who take renal replacement therapy
- •Any type of Neuromuscular disease
- •Body mass index exceed 30
- •Infection that require treatment more than 14 days
研究组 & 干预措施
Polymyxin B
Experimental
Polymyxin B 1.5-2.5 mg/kg/day intravenous q 12 hrs duration 7-14 days
干预措施: Polymyxin B (Drug)
结局指标
主要结局
mortality rate
时间窗: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
mortality rate of gram negative bacteria infected patients receiving Polymyxin B at day 28 after enrollment
次要结局
- microbiological clearance(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Peak Plasma Concentration (Cmax) of polymyxin B(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- adverse drug reactions(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
研究者
研究点 (1)
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