Clinical validation of a dried blood spot (DBS) method for the analysis of rifampicin (RIBOD study).
Withdrawn
- Conditions
- analysis of drugs used for tuberculosis10004018
- Registration Number
- NL-OMON42070
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
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
none
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 rifampicin in the target population. The related endpoint is the evaluation<br /><br>of the the association between the concentration obtained by venous sampling<br /><br>and the concentration obtained by means of DBS sampling. The predictive<br /><br>performance of the DBS method as a measure for the venous concentration will be<br /><br>evaluated.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the feasibility of finger prick DBS in the target population. The<br /><br>related endpoint is the response to a questionnaire. Results will be used to<br /><br>prepare implementation of the novel method for home-based monitoring as well as<br /><br>to prepare a HTA analysis.<br /><br>- To design an inventory of cost types related to DBS sampling and conventional<br /><br>sampling. The cost types will function as<br /><br>a basis for future HTA analysis of this novel sampling method compared to<br /><br>conventional venous sampling.</p><br>