The Clinical Validation of a Dried Blood Spot Method for Vancomycin and Creatinine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-21

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Vancomycin

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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fingerprick

In addition to the standard venous samples, dried blood spot samples trough a fingerprick will be collected.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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dried blood spot sampling

Eligibility Criteria

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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