the Clinical Trial of Teicoplanin for Injection

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03020901
Study type	Observational
Source	Jiangsu Famous Medical Technology Co., Ltd.
Contact	Yingchun Xu, Doctor
Phone	13911303028
Email	xycpumch@139.com
Status	Not yet recruiting
Phase	N/A
Start date	January 2017
Completion date	December 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.