NCT03020901

the Clinical Trial of Teicoplanin for Injection

100000cases Real World Research of the Safety, Efficacy Reassessment, and Bacterial Resistance Monitoring of Teicoplanin for Injection After Listing

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100,000 (estimated)
• Sponsor: Jiangsu Famous Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Infectious Disease

Interventions

Type	Name	Description
DRUG	Teicoplanin for Injection	Use Teicoplanin for Injection

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-08-01
• Completion: 2018-12-01
• First posted: 2017-01-13
• Last updated: 2017-01-13