the Clinical Trial of Teicoplanin for Injection

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

100000cases Real World Research of the Safety, Efficacy Reassessment, and Bacterial Resistance Monitoring of Teicoplanin for Injection After Listing

  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 bacterial resistance Explore the advantages of teicoplanin in combination with other antimicrobial agents Explore the opportunistic use of teicoplanin for injection

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Research purposes

  1. To explore the safety and efficacy of different doses of teicoplanin for injection in the real world
  2. To explore the characteristics of different doses of teicoplanin for injection, the clinical characteristics of drug use and repeated use of bacterial resistance;
  3. Reveal rare or even very rare, new, unanticipated, and adverse drug reactions associated with long-term use;
  4. To explore the advantages of different doses of teicoplanin in combination with other antimicrobial agents;
  5. To explore the use of teicoplanin in the treatment of infectious diseases on the rational use of drugs time;
  6. To reveal the risk factors of adverse reactions and susceptibility to people, to identify the characteristics of the crowd;
  7. 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;
  8. To provide reference for revision of clinical guidelines and consensus, clinical pathway design;
  9. To further enhance the level of safe use of teicoplanin injection, basic medical support and market vitality.

Research design

  1. National, large-scale, standardized, standardized, real-world research;
  2. Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
  3. In the hospitals using teicoplanin for injection, 200 were selected on the basis of voluntary principles;
  4. Registration of teicoplanin in patients with injection;
  5. Target sample size of 100,000 cases;
  6. Exemption from informed consent for ethical review applications;
  7. Study of teicoplanin and large-scale data on the safety and effectiveness of antibiotics.

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 for teicoplanin in patients

Description

Inclusion Criteria:

  • Prescription for teicoplanin 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
Time Frame
Bacterial clearance rate
Time Frame: 1-21 days after injection
1-21 days after injection

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)

August 1, 2018

Study Completion (Anticipated)

December 1, 2018

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

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FM-P5-2016052501

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.

Clinical Trials on Infectious Disease

Clinical Trials on Teicoplanin for Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe