Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorShanghai Children's Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Theraputic drug monitoring
Other interventionHigh Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole
Isavuconazole
DrugIsavuconazole
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Isavuconazole groupOther 2 interventions
Trial outcomes
Primary outcomes
1
Plasma concentrations of isavuconazole
High Performance Liquid Chromatography is used to determine the plasma concentrations of isavuconazole
Time frame
30 minutes before next dosingSecondary outcomes
1
Treatment success rates for IMI
Percentage of patients who were assessed by the study physician as clinically cured and improved
Time frame
6 months2
AE and SAE
Number and percentage of AE and SAE
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov