Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Last updated: December 9, 2024
Sponsor: Shanghai Children's Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Systemic Fungal Infections

Aspergillosis

Treatment

Theraputic drug monitoring

Isavuconazole

Clinical Study ID

NCT06440915
YJK-001
  • Ages < 18
  • All Genders

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 Criteria

Inclusion

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 andoperations specified in the study protocol;

  • The guardian of the subject and the subject of independent informed age are willingand able to provide written informed consent to participate in the study.

Exclusion

Exclusion Criteria:

  • The subject is known to be allergic to any azole antifungal therapy or otheringredients contained in the study drug;

  • The researcher believes that the condition of the child may interfere with studyparticipation or other inappropriate conditions.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Theraputic drug monitoring
Phase:
Study Start date:
June 06, 2024
Estimated Completion Date:
June 30, 2026

Study Description

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.

Connect with a study center

  • Shanghai Children's Medical Center

    Shanghai,
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.