Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Mucormycosis Clinical Trial

Official title:

Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440915
• Other study ID #: YJK-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: Shanghai Children's Medical Center
• Contact: Juan Wu, PhD
• Phone: +8618918397709
• Email: wujuan[@]scmc.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aspergillosis
• Aspergillosis Invasive
• Mucormycosis

Intervention

Other:
• Theraputic drug monitoring
High Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole

Drug:
• Isavuconazole
Isavuconazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Children's Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of isavuconazole	High Performance Liquid Chromatography is used to determine the plasma concentrations of isavuconazole	30 minutes before next dosing
Secondary	Treatment success rates for IMI	Percentage of patients who were assessed by the study physician as clinically cured and improved	6 months
Secondary	AE and SAE	Number and percentage of AE and SAE	6 months