Phase Ⅱ Study on Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 288
- 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 Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.
详细描述
Ceftazidime is a third-generation cephalosporins. Ceftazidime 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 ceftazidime can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of ceftazidime in the treatment-resistant pathogen infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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.
- •Hospital patients or good compliance clinic patients, who were more than 18 years old and less than 70 years old, Gender: both.
- •Patients who do not take other antibiotic medications before screening period.
- •Patients who have no severe liver, kidney and hematopoietic system of diseases (Both AST and ALT are less than 1.5 times of the upper limit of normal and Cr is in normal range)
- •Pathogenic bacteria was resistant to ceftazidime and sensitive to both of test drugs and contrast drugs.
- •Women of childbearing was to be negative pregnancy test and agree to take contraceptive measures during the trial.
- •Patients were volunteers and signed informed consent from.
排除标准
- •Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
- •Pathogenic bacteria was sensitive to ceftazidime or resistant to ceftazidime,test drugs and control drugs.
- •Patients who need to take other antibiotic medicine because of concurrent infection.
- •Patients who took medicine which affected efficacy evaluations and safety evaluations such as aspirin, indomethacin, phenylbutazone, sulfanilamide, disulfiram and probenecid in the trial.
- •Patients who took risks of severe drug interactions because of drug combination.
- •Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
- •Pregnant and Lactating women
- •Drug addicts and alcoholics.
- •Patients who once was selected in this trial.
- •Patients who participated in other clinical trials in the past three months.
研究组 & 干预措施
High dose
Ceftazidime 3g
干预措施: High dose (Drug)
Low dose
Ceftazidime 2g
干预措施: Low dose (Drug)
CFP/SUB
Cefoperazone and sulbactam sodium for injection(2:1)
干预措施: Cefoperazone and Sulbactam Sodium (CFP/SUB) (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)