A Prospective, Multicenter, Randomized, Blinded, Positive Parallel Control Study to Estimate the Efficacy and Safety of Levornidazole Disodium Phosphate for Injection in the Treatment of Postoperative Intra-Abdominal Infections Caused by Anaerobic Bacteria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 696
- 试验地点
- 32
- 主要终点
- Proportion of participants with clinical cure at Test of Cure (TOC) visit
研究概览
简要总结
Anaerobic infections are very common in clinical practice. Poor control of anaerobic infections in patients undergoing abdominal surgery may lead to the occurrence of complications. The aim of this study is to explore the efficacy and safety of Levornidazole Phosphate Disodium for Injection in the treatment of patients with postoperative intra-abdominal infections caused by anaerobic bacteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental Group
干预措施: Levornidazole Disodium Phosphate for Injection (Drug)
Control Group
干预措施: Ornidazole and Sodium Chloride Injection (Drug)
结局指标
主要结局
Proportion of participants with clinical cure at Test of Cure (TOC) visit
时间窗: 5 to 10 days post-therapy
Clinical cure was defined as complete resolution of all symptoms and signs, including the return to normal of non - microbiological indicators such as preoperative imaging and laboratory tests. Symptoms and laboratory tests returned to normal using the following criteria: resolution or improvement of abdominal pain; Body temperature ≤ 37.5°C and white blood cell count \< 10×10\^9/L. persistent or incomplete resolution or worsening of symptoms and signs; or the development of new symptoms or signs and/or the use of other antimicrobial drugs against anaerobes was defined as clinically failure. The percentage of participants with clinical cure or clinical failure at TOC was summarized.
次要结局
- Proportion of participants with clinical cure at End of Therapy (EOT) visit(Up to approximately Day 8)
- Bacteriological efficacy at EOT visit(Up to approximately Day 8)
- Comprehensive efficacy at EOT visit(Up to approximately Day 8)
- Bacteriological efficacy at TOC visit(5 to 10 days post-therapy)
- Comprehensive efficacy at TOC visit(5 to 10 days post-therapy)
- Incidence of phlebitis during treatment(Up to approximately Day 7)
- Percentage of participants who experienced Adverse Events (AEs)(Up to Day 10 post-therapy)