Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Recruiting now · Not applicable

Conditions studied: Aspergillosis Invasive, Mucormycosis

In brief

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.

Key facts

Study ID

NCT06440915

Run by

Shanghai Children's Medical Center

People needed

200

Starts

2024-06-06

Expected to finish

2026-06-30

Last updated by the study team

2024-12-13

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanghai Children's Medical Center — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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