Vancomycin
Conditions
Brief summary
A widely used antibiotic is vancomycin. To ensure adequate exposure to vancomycin, drug doses are adjusted based on whole-blood concentration measurements, a practice known as therapeutic drug monitoring (TDM). The need for TDM of vancomycin is well established, as described in several national and international guidelines, for dose-optimization in order to achieve successful treatment and to prevent toxicity and reduce microbial resistance. A sampling method for TDM that has become more popular over the recent years is dried blood spotting (DBS). DBS is a design of blood sampling consisting of positioning a drop of capillary blood, preferably taken from the finger, on filter paper. Unlike venous blood sampling (the current gold standard for TDM of vancomycin), DBS seems to have advantages for the patient. The finger prick is less invasive than venipuncture. DBS also enables patients to perform one or multiple finger prick(s) themselves, with the possibility to sample at multiple time points. Due to the fact that vancomycin is nephrotoxic, it would be very efficient and convenient to measure creatinine in the same dried blood spot as the vancomycin. This study is a clinical validation study to validate the DBS assay for vancomycin.
Interventions
DIAGNOSTIC_TESTfingerprick
In addition to the standard venous samples, dried blood spot samples trough a fingerprick will be collected.
Sponsors
Erasmus Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical patients * Aged 18 and over * Able to understand written information and able to give informed consent * Treated with vancomycin * Able and willing to undergo a finger prick for dried blood spot sampling * Able and willing to fill in a questionnaire
Exclusion criteria
* Unable to draw blood samples for study purposes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To clinically validate the DBS method for vancomycin and creatinine in comparison to venipuncture vancomycin and creatinine analysis | 5 months |
Secondary
| Measure | Time frame |
|---|---|
| Analyzing the differences in the measured concentrations in the dried blood spot made with blood obtained from venous sampling and capillary sampling. | 5 months |
| Evaluating the need of a correction factor and optimizing the correction factor when measuring the hematocrit in the DBS samples | 5 months |
| To investigate the patients' experience with the DBS method in comparison to venipuncture | 5 months |
Countries
Netherlands
Outcome results
None listed