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

NCT05257070 | Completed

• 1 other identifier: NL79269.078.21
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vancomycin

Outcome Measures

Primary Outcomes (1)

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

  5 months

Secondary Outcomes (3)

• 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

Interventions

fingerprick DIAGNOSTIC_TEST

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

Also known as: dried blood spot sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adults receiving intravenous vancomycin

You may qualify if:

• 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

You may not qualify if:

• Unable to draw blood samples for study purposes

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

Study Officials

• Brenda de Winter, PharmD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: March 21, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)