Therapeutic Drug Monitoring of Teicoplanin in Children

Shandong University1 site in 1 country500 target enrollmentApril 1, 2019

ConditionsBacterial Infections

DrugsTeicoplanin-PMMA

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bacterial Infections
Sponsor: Shandong University
Enrollment: 500
Locations: 1
Primary Endpoint: Plasma drug concentration
Status: Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this study, the therapeutic drug monitoring of teicoplanin is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then we analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of teicoplanin in Chinese children.

Registry

clinicaltrials.gov

Start Date

April 1, 2019

End Date

December 2025

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shandong University

Responsible Party

Principal Investigator

Wei Zhao

Head of department of clinical pharmacy and pharmacology

Shandong University

Eligibility Criteria

Inclusion Criteria

•Teicoplanin was administered intravenously;
•Teicoplanin was used for therapeutic purposes;
•Age:≤18 years;
•Clinician confirms and plans to diagnose the patient with gram-positive coccus infection;
•Patients with therapeutic concentration monitoring of teicoplanin.

Exclusion Criteria

•Teicoplanin was administered non-intravenously;
•Teicoplanin was used for prophylactic purposes;
•Patients without therapeutic concentration monitoring of teicoplanin;
•Patients who die within 24 hours of the use of teicoplanin；
•The blood concentrations of the patient was not approved by the quality control center.