Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Theraputic drug monitoring, Isavuconazole.
- Who it may be relevant to
- Registry conditions: Aspergillosis Invasive, Mucormycosis. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Other Theraputic drug monitoring
High Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole - Drug Isavuconazole
Isavuconazole
Primary outcome measures
- Plasma concentrations of isavuconazole [Time frame: 30 minutes before next dosing]
Secondary outcome measures (2)
- Treatment success rates for IMI [Time frame: 6 months]
- AE and SAE [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Children's Medical Center — Shanghai
Identifiers
NCT: NCT06440915 · YJK-001