immuunsuppressie na niertransplantatie analysis of drug used in renal transplantation / analysis of drug used in invasive fungal infections
Conditions
Interventions
None listed
Sponsors
Afdeling Apotheek
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: • Patients aged between 2 and 18 years • Admitted to the pediatric ward or visiting the doctor on an outpatient basis • Having a venous catheter or blood is drawn for regular patient care • Treated with at least 1 of the 9 drugs of interest • Signed informed consent
Exclusion criteria
Exclusion criteria: • Parents and/or patients are not able to understand the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is the clinical validation of a DBS method for voriconazole, fluconazole, itraconazole, posaconazole, mofetil mycophenolic acid, cyclosporine, tacrolimus, sirolimus and everolimus in the pediatric population. The related endpoint will is the evaluation ofbe the association between the concentration obtained by venous sampling and the concentration obtained by means of DBS sampling. The predictive performance of the DBS method as a measure for the venous concentration will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the feasibility of finger prick DBS in the pediatric population. The related endpoint is the response to a questionnaire. Results will be used to prepare implementation of the novel method for home-based monitoring as well as to prepare a HTA analysis. - To design an inventory of cost types related to DBS sampling and conventional sampling. The cost types will function as a basis for future HTA analysis of this novel sampling method compared to conventional venous sampling. - To use the date already collected for the primary endpoint to construct a population pharmacokinetic model to optimize dosing and design new guidelines of the nine compounds included in this study (voriconazole, fluconazole, itraconazole, posaconazole, mofetil mycophenolic acid, cyclosporine, tacrolimus, sirolimus and everolimus) for the pediatric patient population. Endpoints will be population estimates of the pharmacokinetic parameters AUC, maximal concentration (Cmax), time to maximal concentration (Tmax), clearance (CL), volume of distribution (Vd) and elimination half-life (t1/2). | — |
Countries
Netherlands
Outcome results
None listed