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Clinical Trials in China / NCT06440915
Recruiting Not applicable

Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

NCT06440915 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Children's Medical Center
Phase
Not applicable
Started
2024-06-06
Last updated
2024-12-13

Condition(s) studied

Aspergillosis InvasiveMucormycosis

Investigational drug(s) / intervention(s)

Theraputic drug monitoringIsavuconazole

Theraputic drug monitoring: High Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole

Isavuconazole: Isavuconazole

Study 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.

Eligibility

Sex
ALL
Min age
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Children's Medical Center Shanghai China Recruiting

More Shanghai Children's Medical Center trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06440915 on ClinicalTrials.gov ↗ ← All trials in China