Efficacy and Safety of CRO-SBT Performed in Children With Acute Bacterial Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- The cure rate of patients
研究概览
简要总结
To evaluate the safety and efficacy of treatment of children with acute bacterial infection disease with Ceftriaxone Sodium and Sulbactam Sodium for Injection in the condition of widely used, and provide the basis of adjusting the dosage regimen for children in particular.
详细描述
Ceftriaxone 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 Ceftriaxone can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Ceftriaxone 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
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female children ages≥6 years to< 14 years.
- •Weight≥18kg who in hospital or outpatients with good compliance;
- •The subjects were diagnosed as respiratory infection, urinary tract infection or other infection caused by the compound sensitive bacteria after clinical symptoms and signs laboratory examination and auxiliary examination according to the clinically recognized diagnostic criteria, and should be treated with systemic antibiotics;
- •Subjects had not used effective antimicrobial agents before screening, or had used antimicrobial agents but the efficacy was not obvious;
- •No severe liver and kidney cardiovascular and hematopoietic diseases were found in the subjects (AST and ALT were not more than 1.5 times of the upper limit of normal value,Cr was within the normal range);
- •Subject guardian informed consent and/or subject's own informed consent subject volunteers to participate in this study and has signed the subject's informed consent.
排除标准
- •History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other β-lactam antibiotics;
- •Patients with specific infections who require treatment with other antimicrobial agents;
- •Use of penicillin roxithromycin vitamin B vitamin C and other drugs may interfere with the efficacy or safety evaluation of drugs at the same time;
- •Patients at risk of serious drug interactions due to combination of medications;
- •Patients who have other diseases and thought to affect efficacy evaluations or be poor compliance;
- •Attended clinical trial in three monthes.
研究组 & 干预措施
CRO-SBT
Ceftriaxone Sodium and Sulbactam Sodium for Injection(2:1)
干预措施: Ceftriaxone Sodium and Sulbactam Sodium for Injection (Drug)
结局指标
主要结局
The cure rate of patients
时间窗: Seven days after treatment
Clinically effective/Clinically ineffective
次要结局
- bacterial clearance rate(48 hours after treatment)