analysis of drugs used for tuberculosis
Conditions
Interventions
DBS (dried blood spot)
Rifampicin
TDM (therapeutic drug monitoring)
Validation
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Patients aged 18 or over * Treated at the Radboud University Centre for Chronic Diseases Dekkerswald * Treated with rifampicin * The drug concentration being in steady state
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is the clinical validation of a DBS method for rifampicin in the target population. The related endpoint is the evaluation of the 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 target 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. | — |
Countries
The Netherlands
Outcome results
None listed