Therapeutic Drug Monitoring of Teicoplanin in Children

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.

Study Overview

• Status: Recruiting
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: Teicoplanin-PMMA

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Shandong
    • Ji'nan, Shandong, China, 250014
      • Recruiting
      • Shandong Provincial Qianfoshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with gram-positive coccus infection

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma drug concentration	To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).	Through study completion, an average of 14 days

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Shandong Provincial Hospital; Qianfoshan Hospital; Jinan Central Hospital; The Second Hospital of Shandong University; Yantai Yuhuangding Hospital; Affiliated Hospital of Qinghai University; Shandong Tumor Hospital; Liaocheng People's Hospital; Linyi People's Hospital; Weifang People's Hospital; Jinan children's hospital; Affiliated hospital of jining medical college; Weihai maternal and child health care hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ANTICIPATED): November 1, 2025
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (ACTUAL): May 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Teicoplanin
• Other Study ID Numbers: 2019_Teicoplanin_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No