The Clinical Trial of Cefuroxime Axetil Dispersible Tablets

Infectious Disease Clinical Trial

Official title:

100000 Cases Real World Research of the Safety and Efficacy Revaluation of Cefuroxime Axetil Dispersible Tablets After Listing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03020940
• Other study ID #: FM-P5-2016072201-1
• Status: Not yet recruiting
• Phase: N/A
• First received: January 6, 2017
• Last updated: January 11, 2017
• Start date: January 2017
• Est. completion date: November 2019

Study information

• Verified date: August 2016
• Source: Jiangsu Famous Medical Technology Co., Ltd.
• Contact: Xiaojun Ma, doctor
• Phone: 13911378823
• Email: drmaxiaojun[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100000
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Prescription of cefuroxime axetil dispersible tablets in patients

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease

Intervention

Drug:
• Cefuroxime Axetil Dispersible Tablets
Oral. This product can be taken orally, can also be added to the amount of warm water after mixing evenly. Adult general 0.25g (one time), 2 times a day, the general course of treatment for 5 to 10 days. Severe Infection or suspected pneumonia, a 0.5g (once 2), 2 times a day; general urinary tract infection, a Times a 0.125g (one and a half tablets), 2 times a day; for patients with no complications of gonorrhea recommended dose of 1g (4 Tablets), a single taking. Children generally a dose of 0.125g (one-half tablets), 2 times a day; for less than two years of age in the middle ear Inflammatory patients, a 0.125g (one half tablets), 2 times a day; for greater than two years of otitis media patients, one Times a 0.25g (one time), 2 times a day; more than 12 years of age in children, the same dose for adults

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	1.clear 2.Assume purge 3.Not cleared 4.Assume not cleared 5.Partially cleared 6.replace 7.Re-infection 8.Colonization 9.Can not be evaluated	1 to 14 days after the use of Cefuroxime Axetil Dispersible Tablets,	No