Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

NCT06440915 | Recruiting

• 1 other identifier: YJK-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Aspergillosis Invasive; Mucormycosis

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of isavuconazole

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

  30 minutes before next dosing

Secondary Outcomes (2)

• Treatment success rates for IMI

  6 months

• AE and SAE

  6 months

Study Arms (1)

Isavuconazole group

OTHER

Theraputic drug monitoring

Other: Theraputic drug monitoring; Drug: Isavuconazole

Interventions

Theraputic drug monitoring OTHER

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

Isavuconazole group

Isavuconazole DRUG

Isavuconazole

Isavuconazole group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Mucormycosis

Interventions

isavuconazole

Condition Hierarchy (Ancestors)

Zygomycosis; Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Juan Wu, PhD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Wu, PhD

CONTACT

+8618918397709; wujuan@scmc.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 4, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After publication of the study results
• Access Criteria: Contact the investigator for request

Locations

CN (1)