NCT03020901Unknown不适用
100000cases Real World Research of the Safety, Efficacy Reassessment, and Bacterial Resistance Monitoring of Teicoplanin for Injection After Listing
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
- Primary study endpoint Security Effectiveness
- 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
- To explore the safety and efficacy of different doses of teicoplanin for injection in the real world
- To explore the characteristics of different doses of teicoplanin for injection, the clinical characteristics of drug use and repeated use of bacterial resistance;
- Reveal rare or even very rare, new, unanticipated, and adverse drug reactions associated with long-term use;
- To explore the advantages of different doses of teicoplanin in combination with other antimicrobial agents;
- To explore the use of teicoplanin in the treatment of infectious diseases on the rational use of drugs time;
- To reveal the risk factors of adverse reactions and susceptibility to people, to identify the characteristics of the crowd;
- 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;
- To provide reference for revision of clinical guidelines and consensus, clinical pathway design;
- To further enhance the level of safe use of teicoplanin injection, basic medical support and market vitality.
Research design
- National, large-scale, standardized, standardized, real-world research;
- Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
- In the hospitals using teicoplanin for injection, 200 were selected on the basis of voluntary principles;
- Registration of teicoplanin in patients with injection;
- Target sample size of 100,000 cases;
- Exemption from informed consent for ethical review applications;
- 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
- 否
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
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