The objective of this study is to clinically validate a DBS method for vancomycin and creatinine, using a LC-MS/MS method.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To clinically validate the DBS method for vancomycin and creatinine in
comparison to venipuncture vancomycin and creatinine analysis
Secondary outcome
- Analyzing the differences in the measured concentrations in the dried blood
spot made with blood obtained from venous sampling and capillary sampling.
- Evaluating the need of a correction factor and optimizing the correction
factor when measuring the hematocrit in the DBS samples
- To investigate the patients* experience with the DBS method in comparison to
venipuncture
Background summary
The OPAT service consists of providing antimicrobial therapy by parenteral
infusion without hospitalization. A widely used antibiotic in OPAT 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 drawback of vancomycin use in OPAT
is the need for laboratory monitoring of vancomycin which requires patients to
travel to a blood sampling facility for blood sampling. 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, which may result in less frequent hospital visitations and
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.
Study objective
The objective of this study is to clinically validate a DBS method for
vancomycin and creatinine, using a LC-MS/MS method.
Study design
Cross-sectional observational study.
Study burden and risks
Participants will undergo one fingerprick (approximately 550 microliters blood
will be drawn), which causes mild irritation, and are asked to fill in a short
questionnaire.
An additional cohort of n=20 patients will be included to validate the
correction formula for vancomycin and creatinin. These patients will undergo
one fingerprick and are asked to fill in a short questionnaire.
In future, this DBS method can be used in clinical practice, which uses less
blood volume for therapeutic drug monitoring and can be applied by the patient
at home.
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79269.078.21 |