Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03020901
Enrollment
100000
Registered
2017-01-13
Start date
2017-01-31
Completion date
2018-12-31
Last updated
2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Disease

Brief 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.

Interventions

DRUGTeicoplanin for Injection

Use Teicoplanin for Injection

Sponsors

Jiangsu Famous Medical Technology Co., Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Prescription for teicoplanin in patients

Exclusion criteria

* NO

Design outcomes

Primary

MeasureTime frame
Bacterial clearance rate1-21 days after injection

Contacts

Primary ContactYingchun Xu, Doctor
xycpumch@139.com13911303028

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026