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

Vancomycin Clinical Trial

— ADVANCED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05257070
• Other study ID #: NL79269.078.21
• Status: Recruiting
• Start date: March 21, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: December 2023
• Source: Erasmus Medical Center
• Contact: Brenda de Winter, PharmD
• Phone: 010-7033202
• Email: b.dewinter[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vancomycin

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To clinically validate the DBS method for vancomycin and creatinine in comparison to venipuncture vancomycin and creatinine analysis		5 months
Secondary	Analyzing the differences in the measured concentrations in the dried blood spot made with blood obtained from venous sampling and capillary sampling.		5 months
Secondary	Evaluating the need of a correction factor and optimizing the correction factor when measuring the hematocrit in the DBS samples		5 months
Secondary	To investigate the patients' experience with the DBS method in comparison to venipuncture		5 months