NCT03020940Unknown不适用
100000 Cases Real World Research of the Safety and Efficacy Revaluation of Cefuroxime Axetil Dispersible Tablets After Listing
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100,000
- 主要终点
- Bacterial clearance
研究概览
简要总结
- National, large-scale, standardized, standardized, real-world research;
- Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
- in the use of cefuroxime axetil dispersible tablets in the hospital, according to the principle of voluntary selection of 200;
- registration of the use of cefuroxime axetil dispersion tablets patients;
- Target sample size of 100,000 cases;
- Exemption from informed consent for ethical review applications;
- Antibiotic drug safety re-evaluation of large data.
详细描述
Research purposes
- To evaluate the safety of cefuroxime axetil dispersible tablets in the real world of the widely used population,
Rare or even very rare, new, unanticipated adverse reactions, while revealing adverse reactions
Should be susceptible to risk factors and susceptible populations. 2. To evaluate the efficacy of cefuroxime axetil dispersible tablets in the treatment of the relevant site of infection, including
Including empirical therapy and targeted therapy, to further evaluate the widespread use of cefuroxime dispersible tablets
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescription of cefuroxime axetil dispersible tablets in patients
排除标准
- 未提供
结局指标
主要结局
Bacterial clearance
时间窗: 1 to 14 days after the use of Cefuroxime Axetil Dispersible Tablets,
1.clear 2.Assume purge 3.Not cleared 4.Assume not cleared 5.Partially cleared 6.replace 7.Re-infection 8.Colonization 9.Can not be evaluated
次要结局
未报告次要终点
研究者
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