The Clinical Trial of Cefuroxime Axetil Dispersible Tablets

January 11, 2017 updated by: Jiangsu Famous Medical Technology Co., Ltd.

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

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Anticipated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Prescription of cefuroxime axetil dispersible tablets in patients

Description

Inclusion Criteria:

  • Prescription of cefuroxime axetil dispersible tablets in patients

Exclusion Criteria:

  • no

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial clearance
Time Frame: 1 to 14 days after the use of Cefuroxime Axetil Dispersible Tablets，
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，

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Famous Medical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

January 6, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FM-P5-2016072201-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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