The Clinical Trial of Cefuroxime Axetil Dispersible Tablets

Status Not yet recruiting

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

Clinical Trial Details

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

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.