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

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.

Study Overview

• Status: Completed
• Conditions: Vancomycin
• Intervention / Treatment: Diagnostic test: fingerprick

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adults receiving intravenous vancomycin

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To clinically validate the DBS method for vancomycin and creatinine in comparison to venipuncture vancomycin and creatinine analysis	5 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Brenda de Winter, PharmD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NL79269.078.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No