Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
NCT06440915

Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Led by Shanghai Children's Medical Center · Updated on 2024-12-13

200

Participants Needed

1

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who intend to take isavuconazole for the treatment of invasive mycosis
  • Aged 0-18 years, any gender
  • Participant and guardian willing to follow study procedures
  • Participant and guardian able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Known allergy to any azole antifungal therapy or ingredients in the study drug
  • Condition that the researcher believes may interfere with study participation or is otherwise inappropriate

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Children's Medical Center

Shanghai, China

Actively Recruiting

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Research Team

J

Juan Wu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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