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Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

NCT06440915 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-12-13

No results posted yet for this study

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.

Conditions

  • Aspergillosis Invasive
  • Mucormycosis

Interventions

OTHER

Theraputic drug monitoring

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

DRUG

Isavuconazole

Isavuconazole

Sponsors & Collaborators

  • Shanghai Children's Medical Center

    lead OTHER

Principal Investigators

  • Juan Wu, PhD · Shanghai Children's Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-06
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06440915 on ClinicalTrials.gov