跳至主要内容
临床试验/NCT03020940
NCT03020940Unknown不适用

100000 Cases Real World Research of the Safety and Efficacy Revaluation of Cefuroxime Axetil Dispersible Tablets After Listing

Jiangsu Famous Medical Technology Co., Ltd.0 个研究点目标入组 100,000 人开始时间: 2017年1月最近更新:
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

  1. National, large-scale, standardized, standardized, real-world research;
  2. Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
  3. in the use of cefuroxime axetil dispersible tablets in the hospital, according to the principle of voluntary selection of 200;
  4. registration of the use of cefuroxime axetil dispersion tablets patients;
  5. Target sample size of 100,000 cases;
  6. Exemption from informed consent for ethical review applications;
  7. Antibiotic drug safety re-evaluation of large data.

详细描述

Research purposes

  1. 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

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

申办方类型
Industry
责任方
Sponsor

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