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

NCT05257070 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Vancomycin

Interventions

DIAGNOSTIC_TEST

fingerprick

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

Sponsors & Collaborators

Principal Investigators

  • Brenda de Winter, PharmD · Erasmus Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2025-03-01
Completion
2025-03-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257070 on ClinicalTrials.gov