Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440915
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-20
Brief Title:
Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
Sponsor:
Shanghai Childrens Medical Center
Organization:
Shanghai Childrens Medical Center
Study Overview
Official Title:
Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None