protocolSection identificationModule nctId: NCT06283433, orgStudyIdInfo id: NL83813.078.23, briefTitle: A Dried Blood Spot Sampling Method for Vancomycin and Creatinine Monitoring for OPAT, acronym: ADVANCEDOPAT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-25, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: The Outpatient Parenteral Antibiotic Therapy (OPAT) service consists of providing antimicrobial therapy through parenteral infusion without hospitalization. This service is provided to stable patients otherwise ready for hospital discharge. Generally, the clinical monitoring for this patient population is minimal. However, clinical monitoring of vancomycin, an antibiotic widely used during OPAT, can be intensive primarily due to therapeutic drug monitoring. To ensure optimal treatment and minimize nephrotoxicity and microbial resistance, TDM and monitoring of serum creatinine levels are crucial during vancomycin therapy. TDM of vancomycin with OPAT presents a challenge for patients who must frequently travel to blood sampling facilities or the hospital for measurements. An alternative sampling method for TDM is the dried blood spot (DBS) method, which involves collecting a small drop of capillary blood from a finger prick onto filter paper. By implementing the DBS sampling method, the amount of outpatient visits regarding vancomycin treatment in OPAT can be reduced. Furthermore, the addition of measuring a biochemical parameter, such as renal function with serum creatinine, could lead to even less outpatient visits during OPAT. To date, studies investigating the effectiveness of DBS sampling of vancomycin and creatinine in terms of reducing outpatient visits have not yet been conducted in the OPAT population., conditionsModule conditions: Infection, Bacterial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Finger Prick, interventions name: Venipuncture, outcomesModule primaryOutcomes measure: To compare the number of outpatient visits in the control group versus the intervention group at day 28, secondaryOutcomes measure: Outcomes regarding outpatient visit, secondaryOutcomes measure: Sampling outcomes, secondaryOutcomes measure: Satisfaction with blood sampling based on the theoretical framework of acceptability questionnaire (TFA), secondaryOutcomes measure: Cost outcomes, secondaryOutcomes measure: Clinical outcomes, secondaryOutcomes measure: TDM outcomes, secondaryOutcomes measure: Logistical outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus MC, status: RECRUITING, city: Rotterdam, country: Netherlands, contacts name: Birgit Koch, PharmD, role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False