An Open-Lable Multicenter Prospective Non-Randomized Trial to Assess the Efficacy and Safety of Morinidazole With Surgery in Patients With Suppurative or Gangrenous Appendicitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 614
- 试验地点
- 1
- 主要终点
- Clinical cure Rate
研究概览
简要总结
To assess the efficacy, safety, tissue distribution of target organ and Population Pharmacokinetic (PPK) of morinidazole and sodium chloride injection with surgery in patients with suppurative or gangrenous appendicitis
详细描述
Acute appendicitis is among the most common cause of acute abdominal pain. In patients with complicated acute appendicitis, postoperative, broad-spectrum antibiotics are always recommended. Metronidazole, a member of the nitroimidazole drug class, is included in the regimens recommended for improving anaerobic bacteria coverage. The sideeffects of metronidazole include a metallic taste, nausea, transient neutropenia, and peripheral neuropathy. Antimicrobial resistance to metronidazole has emerged after several decades of worldwide use of the drug. Morinidazole, a National Class I Antimicrobial, is a new type of third-generation nitroimidazole antimicrobial that is used for treating amoebiasis, trichomoniasis, and anaerobic bacterial infections, and which exhibits greater activity and less toxicity than metronidazole.
Morinidazole and Sodium Chloride Injection used in pelvic inflammatory disease or appendicitis cases had been approved by CFDA in 2014. This phase 4 study is to assess the efficacy, safety, tissue distribution of target organ and Population Pharmacokinetic (PPK) of morinidazole in patients with suppurative or gangrenous appendicitis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 and 65 years old
- •A diagnosis of suppurative or gangrenous appendicitis based on:
- •metastatic right lower abdominal pain
- •lower abdominal tenderness and/or rebound tenderness
- •pyrexia (axillary temperature ≥ 37.5 °C), a WBC > 10*109/L on routine blood examination
- •Voluntary signing of written informed consent
排除标准
- •patients with an allergy to nitroimidazole
- •patients with a history of antibiotic therapy within the last 48 hours
- •patients with any condition likely to require broad spectrum antibiotics
- •patients who can not evaluate the efficacy or difficult to complete the desired course of treatment
- •ALT and / or AST ≥ 1.5 times the ULN, and / or serum creatinine ≥ the ULN
- •patients with severe systemic diseases likely to affect therapy (e.g., cardiovascular abnormalities, unstable angina, high blood pressure, severe neuropathy, or epilepsy)
- •patients with other diseases or use other drugs which may interfere with the efficacy or safety of the drug
- •patients who participated other clinical trials within 6 months before the start of the trial
- •Pregnant women, breastfeeding women, women of childbearing age without effective contraceptive
研究组 & 干预措施
morinidazole
morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.
干预措施: morinidazole (Drug)
结局指标
主要结局
Clinical cure Rate
时间窗: 5-10 days
Clinical cure Rate （according to symptoms and signs） at 5-10 days post-therapy
次要结局
- Bacteriological response（Bacterial elimination rate）(5-10 days)
- Clinical cure Rate on the first day(the first day)
- Tissue distribution(5-10 days)
- PPK parameters(5-10 days)