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A Dried Blood Spot Sampling Method for Vancomycin and Creatinine Monitoring for OPAT

NCT06283433 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-02-28

No results posted yet for this study

Summary

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.

Conditions

  • Infection, Bacterial

Interventions

DIAGNOSTIC_TEST

Finger Prick

Blood sample obtained via drop of capillary blood by finger prick onto filter paper

DIAGNOSTIC_TEST

Venipuncture

Blood sample obtained trough venipuncture

Sponsors & Collaborators

Principal Investigators

  • Birgit Koch, PharmD · Erasmus MC University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06283433 on ClinicalTrials.gov