Infectious DiseaseNCT03020901
the Clinical Trial of Teicoplanin for Injection
An observational study of Infectious Disease, run by Jiangsu Famous Medical Technology Co., Ltd..
Trial summary
1. Primary study endpoint Security Effectiveness 2. Secondary study endpoint Extensive use of population characteristics Clinical drug characteristics appropriate crowd characteristics Adverse reactions susceptible population characteristics Reveal rare, new, unanticipated and long-term adverse drug reactions… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Disease
- What is being tested?
- Teicoplanin for Injection
- Type of treatment
- Injection or infusion
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- 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 for teicoplanin in patients
Who may be able to join
- Prescription for teicoplanin in patients
Who cannot join
- NO
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 100000cases Real World Research of the Safety, Efficacy Reassessment, and Bacterial Resistance Monitoring of Teicoplanin for Injection After Listing
- Primary study endpoint Security Effectiveness
- Secondary study endpoint Extensive use of population characteristics Clinical drug characteristics appropriate crowd characteristics Adverse reactions susceptible population characteristics Reveal rare, new, unanticipated and long-term adverse drug reactions bacterial resistance Explore the advantages of teicoplanin in combination with other antimicrobial agents Explore the opportunistic use of teicoplanin for injection
Read the detailed description
Research purposes
- To explore the safety and efficacy of different doses of teicoplanin for injection in the real world
- To explore the characteristics of different doses of teicoplanin for injection, the clinical characteristics of drug use and repeated use of bacterial resistance;
- Reveal rare or even very rare, new, unanticipated, and adverse drug reactions associated with long-term use;
- To explore the advantages of different doses of teicoplanin in combination with other antimicrobial agents;
- To explore the use of teicoplanin in the treatment of infectious diseases on the rational use of drugs time;
- To reveal the risk factors of adverse reactions and susceptibility to people, to identify the characteristics of the crowd;
- To investigate the clinical use of teicoplanin injection for the real situation, for further risk management, to expand the indications and expert consensus dose study to provide clinical clues and basis;
- To provide reference for revision of clinical guidelines and consensus, clinical pathway design;
- To further enhance the level of safe use of teicoplanin injection, basic medical support and market vitality.
Research design
- National, large-scale, standardized, standardized, real-world research;
- Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
- In the hospitals using teicoplanin for injection, 200 were selected on the basis of voluntary principles;
- Registration of teicoplanin in patients with injection;
- Target sample size of 100,000 cases;
- Exemption from informed consent for ethical review applications;
- Study of teicoplanin and large-scale data on the safety and effectiveness of antibiotics.
- Conditions
- Infectious Disease
- Being tested
- Teicoplanin for Injection
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teicoplanin for InjectionDrug
Also called Ta Ge Shi
Use Teicoplanin for Injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial clearance rate
Measured: 1-21 days after injection
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 completionAug 2018 (estimated)
- Study completionDec 2018 (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
- NCT03020901
- Sponsor's protocol ID
- FM-P5-2016052501
- Status last verified
- Jan 2017
- 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
- 100000cases Real World Research of the Safety, Efficacy Reassessment, and Bacterial Resistance Monitoring of Teicoplanin for Injection After Listing
- ClinicalTrials.gov ID
- NCT03020901
- Acronym / sponsor ID
- FM-P5-2016052501
- 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
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (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.
- Primary study endpoint Security Effectiveness
- Secondary study endpoint Extensive use of population characteristics Clinical drug characteristics appropriate crowd characteristics Adverse reactions susceptible population characteristics Reveal rare, new, unanticipated and long-term adverse drug reactions bacterial resistance Explore the advantages of teicoplanin in combination with other antimicrobial agents Explore the opportunistic use of teicoplanin for injection
Detailed description
Research purposes
- To explore the safety and efficacy of different doses of teicoplanin for injection in the real world
- To explore the characteristics of different doses of teicoplanin for injection, the clinical characteristics of drug use and repeated use of bacterial resistance;
- Reveal rare or even very rare, new, unanticipated, and adverse drug reactions associated with long-term use;
- To explore the advantages of different doses of teicoplanin in combination with other antimicrobial agents;
- To explore the use of teicoplanin in the treatment of infectious diseases on the rational use of drugs time;
- To reveal the risk factors of adverse reactions and susceptibility to people, to identify the characteristics of the crowd;
- To investigate the clinical use of teicoplanin injection for the real situation, for further risk management, to expand the indications and expert consensus dose study to provide clinical clues and basis;
- To provide reference for revision of clinical guidelines and consensus, clinical pathway design;
- To further enhance the level of safe use of teicoplanin injection, basic medical support and market vitality.
Research design
- National, large-scale, standardized, standardized, real-world research;
- Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
- In the hospitals using teicoplanin for injection, 200 were selected on the basis of voluntary principles;
- Registration of teicoplanin in patients with injection;
- Target sample size of 100,000 cases;
- Exemption from informed consent for ethical review applications;
- Study of teicoplanin and large-scale data on the safety and effectiveness of antibiotics.
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 for teicoplanin in patients
Key inclusion criteria (1 listed)
- Prescription for teicoplanin 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 |
|---|---|---|
| Teicoplanin for InjectionAlso: Ta Ge ShiUse Teicoplanin for Injection | Drug | – |
Primary outcome
Bacterial clearance rate
Time frame: 1-21 days after injection
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 Yingchun Xu, Doctor (13911303028, xycpumch@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial clearance rate (time frame: 1-21 days after injection). 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.