Monitoring isavuconazole levels in children with invasive fungal infections
Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
This study is testing how well isavuconazole works in children with serious fungal infections by checking their blood levels to make sure they are getting the right amount of the medicine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Shanghai Children's Medical Center Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06440915 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the plasma concentration of isavuconazole in pediatric patients suffering from invasive mycosis, specifically aspergillosis and mucormycosis. The study will involve measuring blood samples taken before the next dose of the medication to determine the effective and safe plasma concentration ranges. By understanding the pharmacokinetics of isavuconazole in children, the research seeks to optimize individualized drug administration and improve treatment outcomes. The study will also evaluate the relationship between plasma concentrations and the efficacy and safety of the drug in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-18 years who are prescribed isavuconazole for the treatment of invasive mycosis.
Not a fit: Patients who are allergic to azole antifungal therapies or have conditions that may interfere with study participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer dosing of isavuconazole for children with serious fungal infections.
How similar studies have performed: While there may be studies on drug monitoring in adults, this specific focus on pediatric pharmacokinetics of isavuconazole is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Shanghai Children's Medical Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Juan Wu, PhD — Shanghai Children's Medical Center
- Study coordinator: Juan Wu, PhD
- Email: wujuan@scmc.com.cn
- Phone: +8618918397709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.