Infectious DiseaseNCT03020940
The Clinical Trial of Cefuroxime Axetil Dispersible Tablets
An observational study of Infectious Disease, run by Jiangsu Famous Medical Technology Co., Ltd..
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Disease
- What is being tested?
- Cefuroxime Axetil Dispersible Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prescription of cefuroxime axetil dispersible tablets in patients
Who may be able to join
- Prescription of cefuroxime axetil dispersible tablets in patients
Who cannot join
- no
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 100000 Cases Real World Research of the Safety and Efficacy Revaluation of Cefuroxime Axetil Dispersible Tablets After Listing
- National, large-scale, standardized, standardized, real-world research;
- Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
- in the use of cefuroxime axetil dispersible tablets in the hospital, according to the principle of voluntary selection of 200;
- registration of the use of cefuroxime axetil dispersion tablets patients;
- Target sample size of 100,000 cases;
- Exemption from informed consent for ethical review applications;
- Antibiotic drug safety re-evaluation of large data.
Read the detailed description
Research purposes
- 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.
- 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.
- 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.
- For the relevant treatment areas of guidance and consensus revision, clinical pathway design provides a reference.
- To further improve the safety of cefuroxime axetil dispersion tablets level, the basic medical security capabilities and Market vitality.
Study end point
- The main study endpoint:
- Security;
- Effectiveness.
- Secondary study endpoint:
- Extensive use of population characteristics;
- Clinical drug characteristics;
- Appropriate characteristics of the crowd;
- Adverse reactions susceptible population characteristics.
- Conditions
- Infectious Disease
- Being tested
- Cefuroxime Axetil Dispersible Tablets
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefuroxime Axetil Dispersible TabletsDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 to 14 days after the use of Cefuroxime Axetil Dispersible Tablets，
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020940
- Sponsor's protocol ID
- FM-P5-2016072201-1
- Status last verified
- Aug 2016
- First submitted
- 6 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 100000 Cases Real World Research of the Safety and Efficacy Revaluation of Cefuroxime Axetil Dispersible Tablets After Listing
- ClinicalTrials.gov ID
- NCT03020940
- Acronym / sponsor ID
- FM-P5-2016072201-1
- Conditions
- Infectious Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- National, large-scale, standardized, standardized, real-world research;
- Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
- in the use of cefuroxime axetil dispersible tablets in the hospital, according to the principle of voluntary selection of 200;
- registration of the use of cefuroxime axetil dispersion tablets patients;
- Target sample size of 100,000 cases;
- Exemption from informed consent for ethical review applications;
- Antibiotic drug safety re-evaluation of large data.
Detailed description
Research purposes
- 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.
- 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.
- 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.
- For the relevant treatment areas of guidance and consensus revision, clinical pathway design provides a reference.
- To further improve the safety of cefuroxime axetil dispersion tablets level, the basic medical security capabilities and Market vitality.
Study end point
- The main study endpoint:
- Security;
- Effectiveness.
- 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
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prescription of cefuroxime axetil dispersible tablets in patients
Key inclusion criteria (1 listed)
- Prescription of cefuroxime axetil dispersible tablets in patients
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefuroxime Axetil Dispersible TabletsOral. 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 | Drug | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease, run by Jiangsu Famous Medical Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojun Ma, doctor (13911378823, drmaxiaojun@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial clearance (time frame: 1 to 14 days after the use of Cefuroxime Axetil Dispersible Tablets，). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.