Clinical trial · Observational
Clinical Validation of a Dried Blood Spot Method for Analysis of Immunosuppressives and Antifungals in Pediatrics
Clinical Validation of a Dried Blood Spot (DBS) Method for the Analysis of Immunosuppressive and Antifungal Drugs in Pediatric Patients (Part of the PROTECT Study).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a clincial validation study of a dried blood spot (DBS) method for the analysis of immunosuppressive and antifungal agents currently subject of therapeutic drug monitoring (TDM) in a pediatric population. The primary goal is to clinically validate a finger prick DBS method compared to conventional venous sampling for the analysis of 5 immunosuppressive and 4 azole antifungal drugs in the pediatric population. Secondairy goals include feasibility of the finger prick DBS method in the target population, to design an inventory of costs that will be incurred in future health-economic analyses and to construct a population PK model based on the available data collected for the primariy goal.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Diseases | — | UNRESOLVED | — |
| Kidney Diseases | — | UNRESOLVED | — |
| Oncology Problem | — | UNRESOLVED | — |
| Transplantation Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood drawing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- label
- Mycophenolic acid
- description
- Patients treated for their regular patient care with mycophenolic acid.
- interventionNames
- Procedure: blood drawing
- label
- Cyclosporin
- description
- Patients treated for their regular patient care with cyclosporin.
- interventionNames
- Procedure: blood drawing
- label
- Tacrolimus
- description
- Patients treated for their regular patient care with tacrolimus.
- interventionNames
- Procedure: blood drawing
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged between 2 and 18 years * Admitted to the Radboudumc pediatric ward * Having a venous catheter * Treated with at least 1 of the 9 drugs of interest * The drug concentration being at steady state * Signed informed consent Exclusion Criteria: * Parents and/or patients are not able to understand the Dutch language
References
Publications (0)
Data not yet available