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

NCT06283433 | Recruiting

• 1 other identifier: NL83813.078.23
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

microsampling; vancomycin; creatinine; dried blood spot

Outcome Measures

Primary Outcomes (1)

• To compare the number of outpatient visits in the control group versus the intervention group at day 28

  Number of outpatient visits

  28 days after discharge

Secondary Outcomes (7)

• Outcomes regarding outpatient visit

  28 days after discharge

• Sampling outcomes

  28 days after discharge

• Satisfaction with blood sampling based on the theoretical framework of acceptability questionnaire (TFA)

  28 days after discharge

• Cost outcomes

  28 days after discharge

• Clinical outcomes

  28 days after discharge

Study Arms (2)

Control Group (venipuncture)

ACTIVE COMPARATOR

Conventional blood sampling via venipuncture method by a skilled drawing facility

Diagnostic Test: Venipuncture

Intervention Group (DBS)

EXPERIMENTAL

Blood sampling via dried blood spotting (DBS) method at patient's home

Diagnostic Test: Finger Prick

Interventions

Finger Prick DIAGNOSTIC_TEST

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

Also known as: Dried Blood Spot Sampling

Intervention Group (DBS)

Venipuncture DIAGNOSTIC_TEST

Blood sample obtained trough venipuncture

Control Group (venipuncture)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Former participation in this trial
• Cognitive dysfunction or other dysfunctionalities which makes the patient unable to draw blood by a finger prick 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)

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Bacterial Infections

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Birgit Koch, PharmD

  Erasmus MC University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgit Koch, PharmD

CONTACT

0107033202; b.koch@erasmusmc.nl

Moska Hassanzai, PharmD

CONTACT

0107033202; m.hassanzai@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: February 28, 2024
• Study Start: October 25, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

NL (1)