Therapeutic Drug Monitoring of Teicoplanin in Children

Bacterial Infections Clinical Trial

Official title:

Therapeutic Drug Monitoring of Teicoplanin in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03933748
• Other study ID #: 2019_Teicoplanin_001
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: December 2025

Study information

• Verified date: April 2019
• Source: Shandong University
• Contact: Wei Zhao, Ph.D
• Phone: 86053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Drug:
• Teicoplanin-PMMA
Therapeutic drug monitoring of teicoplanin

Locations

Country	Name	City	State
China	Shandong Provincial Qianfoshan Hospital	Ji'nan	Shandong

Sponsors (14)

Lead Sponsor

Collaborator

Shandong University

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

Country where clinical trial is conducted

China, 

Outcome

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