Prevention or treatment of invasive fungal disease
Conditions
Interventions
Experiential administration. - Posaconazole:Before the 7th day of medication, blood samples were collected for the determination of posaconazole concentration
Experiential administration - Posaconazole + cyclosporine:Before the 7th day of medication, blood samples were collected for the determination of posaconazole and cyclosporine concentrations
PBPK model guided administration-Posaconzole:PBPK model prediction were used to guide the individual prescription of Posaconazole
PBPK model guided administration-Posaconzole:Before the 7th day of medication, blood samples were collected for the determination of posaconazole concentration
PBPK model guided administration-Posaconzole+cyclosporine:PBPK model prediction were used to guide the individual prescription of Posaconazole and cyclosporine
PBPK model guided administration-Posaconzole+cyclosporine:Before the 7th day of medication, blood samples were collected for the determination of posaconazole and cyclosporine concentrations
Sponsors
Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Patients who intended to take Posaconazole suspension orally for the prevention or treatment of invasive fungal diseases; 2. Age 0-18, no gender limitation; 3. Subjects receiving treatment with or without cyclosporine; 4. Subjects are expected to use Posaconazole suspension for at least 7 days; 5. Subjects and their guardians are willing to abide by the procedures and operations stipulated in the study protocol; 6. Subject guardians and subjects of independent informed age are willing and able to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. The subject had refractory invasive fungal disease that had not responded to previous antifungal therapy; 2. The subject is known to be allergic to any azole antifungal therapy or other ingredients contained in the study drug; 3. The researcher considers that the condition of the subject may interfere with the study participation or other unsuitable conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of plasma concentration of Posaconazole;Success rate of blood concentration of cyclosporine;The difference between predicted value and measured value of posaconazole plasma concentration;The difference between predicted value and measured value of cyclosporine blood concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of prevention or treatment of IFD (Invasive fungal disease); | — |
Countries
China
Contacts
Public ContactWu Juan
Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed