The Clinical Trial of Cefuroxime Axetil Dispersible Tablets

Jiangsu Famous Medical Technology

Status: Unknown

Conditions: Infectious Disease

Treatments: Drug: Cefuroxime Axetil Dispersible Tablets

Study type: Observational

Funder types: Industry

Identifiers

NCT03020940

FM-P5-2016072201-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prescription of cefuroxime axetil dispersible tablets in patients

Exclusion criteria

• no