The Clinical Trial of Cefuroxime Axetil Dispersible Tablets

NCT03020940 | Unknown

• 1 other identifier: FM-P5-2016072201-1
• Study Type: observational
• Target: 100,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.National, large-scale, standardized, standardized, real-world research;
2. 2.Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
3. 3.in the use of cefuroxime axetil dispersible tablets in the hospital, according to the principle of voluntary selection of 200;
4. 4.registration of the use of cefuroxime axetil dispersion tablets patients;
5. 5.Target sample size of 100,000 cases;
6. 6.Exemption from informed consent for ethical review applications;
7. 7.Antibiotic drug safety re-evaluation of large data.

Conditions

Infectious Disease

Outcome Measures

Primary Outcomes (1)

• 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，

Interventions

Cefuroxime Axetil Dispersible Tablets DRUG

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prescription of cefuroxime axetil dispersible tablets in patients

You may qualify if:

• Prescription of cefuroxime axetil dispersible tablets in patients

Sponsors & Collaborators

• Jiangsu Famous Medical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Communicable Diseases

Interventions

cefuroxime axetil

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaojun Ma, doctor

CONTACT

13911378823; drmaxiaojun@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 13, 2017
• Study Start: January 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 13, 2017

Record last verified: 2016-08