Therapeutic Drug Monitoring of Teicoplanin in Children

Recruiting

• Conditions: Bacterial Infections

• Registration Number: NCT03933748
• Lead Sponsor: Shandong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-04-01
• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-01
• Last Update Submitted: 2020-04-11
• Last Update Posted: 2020-04-14
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shandong Provincial Qianfoshan Hospital; 🇨🇳 Ji'nan, Shandong, China