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NCT Number: NCT06440915

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.

Recruiting

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Key information

Conditions

Aspergillosis Invasive Bacterial Infections and Mycoses Infections Mucormycosis Mycoses Zygomycosis

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Children's Medical Center

Shanghai, China

Location status: Recruiting

Location contact

Juan Wu

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Theraputic drug monitoring

Other

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

Isavuconazole

Drug

Isavuconazole

Primary outcomes

  1. Plasma concentrations of isavuconazole

    Time frame: 30 minutes before next dosing

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

Secondary outcomes

  1. Treatment success rates for IMI

    Time frame: 6 months

    Percentage of patients who were assessed by the study physician as clinically cured and improved

  2. AE and SAE

    Time frame: 6 months

    Number and percentage of AE and SAE

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Wu, PhD

CONTACT

[email protected]

+8618918397709

Sponsors and collaborators

Lead sponsor

Shanghai Children's Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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