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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.
Age
0 - 18 years
Sex
ALL
Healthy Volunteers
No
Shanghai Children's Medical Center
Shanghai, China
Start Date
June 6, 2024
Primary Completion Date
June 30, 2026
Completion Date
June 30, 2026
Last Updated
December 13, 2024
200
ESTIMATED participants
Theraputic drug monitoring
OTHER
Isavuconazole
DRUG
Lead Sponsor
Shanghai Children's Medical Center
NCT07185503
NCT06878144
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06267326