Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Shanghai Children's Medical Center200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Aspergillosis Invasive Mucormycosis

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who intend to take isavuconazole for the treatment of invasive mycosis; * Aged 0-18 years, gender unlimited; * The subject and his/her guardian are willing to comply with the procedures and operations specified in the study protocol; * The guardian of the subject and the subject of independent informed age are willing and able to provide written informed consent to participate in the study. Exclusion Criteria: * The subject is known to be allergic to any azole antifungal therapy or other ingredients contained in the study drug; * The researcher believes that the condition of the child may interfere with study participation or other inappropriate conditions.

Outcomes

Primary Outcomes

Plasma concentrations of isavuconazole

High Performance Liquid Chromatography is used to determine the plasma concentrations of isavuconazole

Time frame: 30 minutes before next dosing

Secondary Outcomes

Treatment success rates for IMI

Percentage of patients who were assessed by the study physician as clinically cured and improved

Time frame: 6 months

AE and SAE

Number and percentage of AE and SAE