the Clinical Trial of Teicoplanin for Injection

Infectious Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03020901
• Other study ID #: FM-P5-2016052501
• Status: Not yet recruiting
• Phase: N/A
• First received: January 6, 2017
• Last updated: January 11, 2017
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Jiangsu Famous Medical Technology Co., Ltd.
• Contact: Yingchun Xu, Doctor
• Phone: 13911303028
• Email: xycpumch[@]139.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100000
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Prescription for teicoplanin in patients

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease

Intervention

Drug:
• Teicoplanin for Injection
Use Teicoplanin for Injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Famous Medical Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial clearance rate		1-21 days after injection	No