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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53282
Enrollment
88
Registered
2023-07-06
Start date
2023-11-01
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

concentration of antibiotic in blood following infection

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
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, com

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)