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OpenTrials
Completed

NCT Number: NCT05257070

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus MC

Rotterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fingerprick

Diagnostic Test

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

Other names: dried blood spot sampling

Primary outcomes

  1. To clinically validate the DBS method for vancomycin and creatinine in comparison to venipuncture vancomycin and creatinine analysis

    Time frame: 5 months

Secondary outcomes

  1. Analyzing the differences in the measured concentrations in the dried blood spot made with blood obtained from venous sampling and capillary sampling.

    Time frame: 5 months

  2. Evaluating the need of a correction factor and optimizing the correction factor when measuring the hematocrit in the DBS samples

    Time frame: 5 months

  3. To investigate the patients' experience with the DBS method in comparison to venipuncture

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: ADVANCED

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2022
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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