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Clinical Trial Summary

1. National, large-scale, standardized, standardized, real-world research;

2. Prospective, single - arm open, non - interventional, registration, multi - center clinical study;

3. in the use of cefuroxime axetil dispersible tablets in the hospital, according to the principle of voluntary selection of 200;

4. registration of the use of cefuroxime axetil dispersion tablets patients;

5. Target sample size of 100,000 cases;

6. Exemption from informed consent for ethical review applications;

7. Antibiotic drug safety re-evaluation of large data.


Clinical Trial Description

Research purposes

1. To evaluate the safety of cefuroxime axetil dispersible tablets in the real world of the widely used population,

Rare or even very rare, new, unanticipated adverse reactions, while revealing adverse reactions

Should be susceptible to risk factors and susceptible populations.

2. To evaluate the efficacy of cefuroxime axetil dispersible tablets in the treatment of the relevant site of infection, including

Including empirical therapy and targeted therapy, to further evaluate the widespread use of cefuroxime dispersible tablets

The validity of the crowd in the real world.

3. To investigate the clinical application of cefuroxime axetil dispersible tablets for the safety management of drug use.

Clinical management should provide more clinical clues and basis.

4. For the relevant treatment areas of guidance and consensus revision, clinical pathway design provides a reference.

5. To further improve the safety of cefuroxime axetil dispersion tablets level, the basic medical security capabilities and Market vitality.

Study end point

1. The main study endpoint:

- Security;

- Effectiveness.

2. Secondary study endpoint:

- Extensive use of population characteristics;

- Clinical drug characteristics;

- Appropriate characteristics of the crowd;

- Adverse reactions susceptible population characteristics. ;


Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT03020940
Study type Observational
Source Jiangsu Famous Medical Technology Co., Ltd.
Contact Xiaojun Ma, doctor
Phone 13911378823
Email drmaxiaojun@sina.com
Status Not yet recruiting
Phase N/A
Start date January 2017
Completion date November 2019

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