NCT06440915

Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shanghai Children's Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. It will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. The main questions it aims to answer are: What is the plasma concentration after using isavuconazole in pediatric patients? What is the effective range of plasma concentration of isavuconazole in pediatric patients? What is the safe range of plasma concentration of isavuconazole in pediatric patients? Researchers will measure the plasma concentration of isavuconazole to see whether it is appropriate. Participants will: Take drug isavuconazole as prescribed by the doctor; 1mL of blood is drawn 30min before the next dose.

Detailed description

Objectives of Study: Main objective: To monitor the plasma concentration of isavuconazole in children, and to study the pharmacokinetic characteristics of isavuconazole in children, so as to provide basis for the optimization of individualized drug administration. Secondary objective: To evaluate the relevance of isavuconazole plasma concentrations to efficacy and safety in pediatric patients.

Conditions

• Aspergillosis Invasive
• Mucormycosis

Interventions

Type	Name	Description
OTHER	Theraputic drug monitoring	High Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole
DRUG	Isavuconazole	Isavuconazole

Timeline

• Start date: 2024-06-06
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-06-04
• Last updated: 2024-12-13

Locations

1 site across 1 country: China