Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Launched by SHANGHAI CHILDREN'S MEDICAL CENTER · Jun 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called isavuconazole, which is used to treat serious fungal infections like aspergillosis and mucormycosis in children. The researchers want to find out how much of the drug is present in the blood of pediatric patients after they take it, and to understand what levels are safe and effective for treating their infections. By measuring the amount of isavuconazole in the blood, they hope to ensure that children are getting the right dose to help them recover.

To participate in this study, children aged 0 to 18 who are prescribed isavuconazole for their fungal infection may be eligible, as long as they or their guardians agree to follow the study's procedures and provide consent. Participants will need to have a small blood sample taken before their next dose of medication. It's important to note that children who have allergies to certain antifungal medications or have other health conditions that could affect their participation may not be eligible. This trial is currently recruiting participants, and your child's involvement could help improve treatment for future patients.

Gender

ALL

Eligibility criteria

• 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.

Trial Officials