Phase IV Study on Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The rate of bacterial clearance
研究概览
简要总结
In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.
详细描述
Piperacillin sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis，the latter making irreversible competitive inhibition of β-lactamase.The antimicrobial effect of Piperacillin can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Piperacillin in the treatment-resistant pathogen infections.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
- •Age>18 years old, Gender: both
- •Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
- •patients were volunteers and signed informed consent form;
- •patients did not participate in other clinical trials.
排除标准
- •Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
- •Pregnant and Lactating women
- •Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
- •Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
研究组 & 干预措施
Piperacillin Sodium and Sulbactam Sodium
Drug:xintemie 1.5-3.0g,iv,bid 7-14 days
serious infections 6.0-12.0g,iv,tid for 7-14 days
干预措施: Piperacillin Sodium and Sulbactam Sodium (Drug)
结局指标
主要结局
The rate of bacterial clearance
时间窗: two years
end of treatment of bacteriological efficacy(bactercial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs
次要结局
- Number of participants with Adverse Events(two years)