Monitoring isavuconazole levels in children with invasive fungal infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the plasma concentration of isavuconazole in pediatric patients suffering from invasive mycosis, specifically aspergillosis and mucormycosis. The study will involve measuring blood samples taken before the next dose of the medication to determine the effective and safe plasma concentration ranges. By understanding the pharmacokinetics of isavuconazole in children, the research seeks to optimize individualized drug administration and improve treatment outcomes. The study will also evaluate the relationship between plasma concentrations and the efficacy and safety of the drug in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Children's Medical Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Juan Wu, PhD — Shanghai Children's Medical Center
• Study coordinator: Juan Wu, PhD
• Email: wujuan@scmc.com.cn
• Phone: +8618918397709

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.