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).
Completed
- Conditions
- immuunsuppressie na niertransplantatieanalysis of drug used in renal transplantation / analysis of drug used in invasive fungal infections10017528
- Registration Number
- NL-OMON44369
- Lead Sponsor
- Afdeling Apotheek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 89
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
• Parents and/or patients are not able to understand the Dutch language
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is the clinical validation of a DBS method<br /><br>for voriconazole, fluconazole, itraconazole, posaconazole, mofetil mycophenolic<br /><br>acid, cyclosporine, tacrolimus, sirolimus and everolimus in the pediatric<br /><br>population. The related endpoint will is the evaluation ofbe the association<br /><br>between the concentration obtained by venous sampling and the concentration<br /><br>obtained by means of DBS sampling. The predictive performance of the DBS method<br /><br>as a measure for the venous concentration will be evaluated. </p><br>
- Secondary Outcome Measures
Name Time Method