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Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

NCT ID: NCT06440915

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-06

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Aspergillosis Invasive Mucormycosis

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Isavuconazole group

Theraputic drug monitoring

Group Type OTHER

Theraputic drug monitoring

Intervention Type OTHER

High Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole

Isavuconazole

Intervention Type DRUG

Isavuconazole

Interventions

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Theraputic drug monitoring

High Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole

Intervention Type OTHER

Isavuconazole

Isavuconazole

Intervention Type DRUG

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Juan Wu, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Children's Medical Center

Locations

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Shanghai Children's Medical Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Juan Wu, PhD

Role: CONTACT

Phone: +8618918397709

Email: [email protected]

Facility Contacts

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Juan Wu

Role: primary

Other Identifiers

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YJK-001

Identifier Type: -

Identifier Source: org_study_id