Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

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.

Study Overview

• Status: Recruiting
• Conditions: Mucormycosis; Aspergillosis Invasive
• Intervention / Treatment: Other: Theraputic drug monitoring; Drug: Isavuconazole

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Wu, PhD; Phone Number: +8618918397709; Email: wujuan@scmc.com.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Children's Medical Center
    • Contact: Juan Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Isavuconazole group; Theraputic drug monitoring	Other: Theraputic drug monitoring; High Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole; Drug: Isavuconazole; Isavuconazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations of isavuconazole	High Performance Liquid Chromatography is used to determine the plasma concentrations of isavuconazole	30 minutes before next dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success rates for IMI	Percentage of patients who were assessed by the study physician as clinically cured and improved	6 months
AE and SAE	Number and percentage of AE and SAE	6 months

Collaborators and Investigators

• Sponsor: Shanghai Children's Medical Center
• Investigators: Principal Investigator: Juan Wu, PhD, Shanghai Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: June 1, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Aspergillosis; Mucormycosis; Zygomycosis; Anti-Infective Agents; Antifungal Agents; Isavuconazole
• Other Study ID Numbers: YJK-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Date of sharing: after publication of the study results; Way of sharing: Contact the investigator for request
• IPD Sharing Time Frame: After publication of the study results
• IPD Sharing Access Criteria: Contact the investigator for request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No