Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Not Applicable

Recruiting

• Conditions: Aspergillosis Invasive; Mucormycosis
• Interventions: Other: Theraputic drug monitoring; Drug: Isavuconazole

• Registration Number: NCT06440915
• Lead Sponsor: Shanghai Children's Medical Center

Brief 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.

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 Timeline

• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-06-01
• Study First Posted: 2024-06-04
• Study Start: 2024-06-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Isavuconazole group	Theraputic drug monitoring	Theraputic drug monitoring
Isavuconazole group	Isavuconazole	Theraputic drug monitoring

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of isavuconazole	30 minutes before next dosing	High Performance Liquid Chromatography is used to determine the plasma concentrations of isavuconazole

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Children's Medical Center; 🇨🇳 Shanghai, China