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临床试验/NCT03020901
NCT03020901Unknown不适用

100000cases Real World Research of the Safety, Efficacy Reassessment, and Bacterial Resistance Monitoring of Teicoplanin for Injection 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
相关药物

试验速览

阶段
不适用
入组人数
100,000
主要终点
Bacterial clearance rate

研究概览

简要总结

  1. Primary study endpoint Security Effectiveness
  2. Secondary study endpoint Extensive use of population characteristics Clinical drug characteristics appropriate crowd characteristics Adverse reactions susceptible population characteristics Reveal rare, new, unanticipated and long-term adverse drug reactions bacterial resistance Explore the advantages of teicoplanin in combination with other antimicrobial agents Explore the opportunistic use of teicoplanin for injection

详细描述

Research purposes

  1. To explore the safety and efficacy of different doses of teicoplanin for injection in the real world
  2. To explore the characteristics of different doses of teicoplanin for injection, the clinical characteristics of drug use and repeated use of bacterial resistance;
  3. Reveal rare or even very rare, new, unanticipated, and adverse drug reactions associated with long-term use;
  4. To explore the advantages of different doses of teicoplanin in combination with other antimicrobial agents;
  5. To explore the use of teicoplanin in the treatment of infectious diseases on the rational use of drugs time;
  6. To reveal the risk factors of adverse reactions and susceptibility to people, to identify the characteristics of the crowd;
  7. To investigate the clinical use of teicoplanin injection for the real situation, for further risk management, to expand the indications and expert consensus dose study to provide clinical clues and basis;
  8. To provide reference for revision of clinical guidelines and consensus, clinical pathway design;
  9. To further enhance the level of safe use of teicoplanin injection, basic medical support and market vitality.

Research design

  1. National, large-scale, standardized, standardized, real-world research;
  2. Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
  3. In the hospitals using teicoplanin for injection, 200 were selected on the basis of voluntary principles;
  4. Registration of teicoplanin in patients with injection;
  5. Target sample size of 100,000 cases;
  6. Exemption from informed consent for ethical review applications;
  7. Study of teicoplanin and large-scale data on the safety and effectiveness of antibiotics.

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 for teicoplanin in patients

排除标准

  • 未提供

结局指标

主要结局

Bacterial clearance rate

时间窗: 1-21 days after injection

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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