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Treffer: A Dried blood spot sampling method for VANcomycin and Creatinine monitoring: Effectiveness Demonstrated in Outpatient Parenteral Antibiotic Therapy service - ADVANCED OPAT

Title:
A Dried blood spot sampling method for VANcomycin and Creatinine monitoring: Effectiveness Demonstrated in Outpatient Parenteral Antibiotic Therapy service - ADVANCED OPAT
Publisher Information:
Erasmus MC, Universitair Medisch Centrum Rotterdam, 2025.
Publication Year:
2025
Original Identifier:
NL83813.078.23
Document Type:
Report Report
Language:
English
Health Condition(s) or Problem(s) studied:
concentration of antibiotic in blood following infection;10004018
Interventions:

Key inclusion & exclusion criteria:
Exclusion criteria:

- Former participation in this trial - Cognitive dysfunction or other dysfunctionalities which makes the patient unable to draw blood by a fingerprick or fill out questionnaires - Unable to sample an adequate DBS after training in the hospital (this is also applicable for family members or other caregivers who are failing to perform adequate DBS sampling for the patient)



Inclusion criteria: - Aged 18 and over - Able to understand written information and able to give informed consent - Hospitalized - Treated with intravenous vancomycin and to be discharged with vancomycin OPAT service with minimal 1 planned outpatient vancomycin TDM order - Able and willing to perform finger pricks for dried blood spot sampling, or able and willing to undergo finger pricks performed by family members or other caregivers - Able and willing to fill in questionnaires
Primary Outcomes:

The main study parameter is the amount of outpatient visits regarding vancomycin therapy.

Recruitment Status:
Pending
Secondary Outcomes:

Outcomes regarding outpatient visits - To compare the amount of outpatient visits with the sole purpose of vancomycin TDM in the control group versus intervention group (phlebotomy visits) - To compare the amount of outpatient visits with the sole purpose of laboratory sampling (with and without TDM) in the control group versus intervention group - To compare the amount of outpatient visits regarding vancomycin therapy without laboratory sampling in the control group versus intervention group - To compare the amount of outpatient visits regarding vancomycin therapy including laboratory sampling (with and without TDM) in the control group versus intervention group - To compare the amount of VNC therapy related telephone consultations in the control group versus intervention group Sampling outcomes - To compare the amount of correct blood sampling in the control group versus intervention group - To investigate the DBS sampling quality - To investigate how many patients are failing DBS (and are subsequently switched to conventional blood sampling) - To explore the facilitators and barriers for (in)correct DBS sampling - Amount of patients unable to perform fingerprick after training in the hospital - To explore potential determinants for patients who are failing or passing DBS sampling under supervision after training (determinants taken into account are e.g. demographic factors (age, sex, weight), use of anticoagulans, sampling by patient or by family member/caregiver) Satisfaction and quality of life outcomes - To investigate if dried blood spot sampling of vancomycin leads to a higher patient satisfaction compared with conventional sampling in OPAT service. - To explore potential determinants for patient satisfaction; determinants taken into account are e.g. demographic factors (age, sex, weight), geographic factors (distance to sampling facility, mode of transportation to sampling facility), medical factors (treatment infection, comorbidities, duration of antibiotic treatment, outpatient visits, time to discharge), sampling factors (DBS sampling by patient or by family member/caregiver, conventional sampling by venepuncture or by drawing blood from line), patient costs and costs related to loss of productivity. - To investigate if dried blood spot sampling of vancomycin leads to a higher quality of life compared with conventional sampling in OPAT service. Cost outcomes - To compare patient costs in the control group versus intervention group - To compare costs related to loss of productivity in the control group versus intervention group - To compare health care costs in the control group versus intervention group - To compare societal costs (total of all costs) in the control group versus intervention group Clinical outcomes - To compare clinical outcomes (e.g. reinfection, readmission, complications, duration of treatment, mortality) in the control group versus intervention group - To compare the relative amount of nephrotoxicity occurrence (defined as in the RIFLE criteria) in the control group versus intervention group - To compare the time to discharge after signing up for OPAT in the control group versus intervention group - To compare the duration of hospital stay in the control group versus intervention group TDM outcomes - To compare the relative amount of creatinine measurements in the control group versus intervention group - To compare the relative amount of vancomycin measurements in the control group versus intervention group - To compare the relative time of vancomycin levels in the therapeutic range in the control group versus intervention group - To compare the amount of dosage changes of vancomycin therapy in the control group versus intervention group - To compare the time to achieving the therapeutic range of vancomycin levels after dosage changes in the control group versus intervention group Logistical outcomes - To compare the time of vancomycin blood sample arrival at the lab after sampling in the control group versus intervention group

Study Design:
Randomized controlled trial, Open (masking not used), Parallel, Diagnostic
Study Type:
Observational
Target Sample Size:
88
Accession Number:
edsict.NL.OMON53282
Database:
International Clinical Trials Registry Platform ICTRP