Actively Recruiting
Study on Therapeutic Drug Monitoring and Pharmacokinetics of Isavuconazole in Children with Invasive Fungal Infections
Led by Shanghai Children's Medical Center · Updated on 2024-12-13
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the plasma concentration and pharmacokinetics of isavuconazole in children aged 0 to 18 years who are being treated for invasive mycosis, including Aspergillosis and Mucormycosis. The study aims to determine the effective and safe plasma concentration ranges of isavuconazole in pediatric patients and how these concentrations relate to treatment success and safety. Participants will take isavuconazole as prescribed by their doctor. The study uses therapeutic drug monitoring with High Performance Liquid Chromatography (HPLC) to measure plasma concentrations of isavuconazole. Blood samples of 1 mL will be collected 30 minutes before the next dose to assess drug levels. During the study, participants will be monitored for plasma drug concentration, treatment effectiveness over six months, and any adverse events. Researchers will evaluate blood samples and collect safety data to help optimize individualized dosing. The study is expected to run until June 2026, with participants involved in monitoring during their treatment period.
CONDITIONS
Brief Title
Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who intend to take isavuconazole for the treatment of invasive mycosis
- Aged 0 to 18 years, any gender
- Willing to comply with study procedures and operations
- Able to provide written informed consent by the subject or guardian
You will not qualify if you...
- Known allergy to any azole antifungal therapy or ingredients in the study drug
- Condition that may interfere with study participation or deemed inappropriate by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of isavuconazole treatment as prescribed
Participants receive isavuconazole and undergo therapeutic drug monitoring to measure plasma concentrations of the drug.
Visits timed around dosing to collect plasma samples, including 30 minutes before next dosing
Duration - Up to 6 months
Participants are monitored to evaluate treatment success and any adverse events for up to 6 months after treatment.
Follow-up visits as scheduled during 6-month monitoring period
Trial Site Locations
Total: 1 location
1
Shanghai Children's Medical Center
Shanghai, China
Actively Recruiting
Research Team
J
Juan Wu, PhD
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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