First Time Right of Vancomycin

NCT ID: NCT05964114

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2026-06-30

Brief Summary

In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug concentrations after continuous administration of the first vancomycin dose. Many beneficial population pharmacokinetic (PPK) models are available however these are prevented from being widely implemented in daily practice due to the complexity. The aim of this study is to evaluate the effectiveness of individualized dosing with PPK models using a newly developed user-friendly pharmacokinetic (PK) tool.

In a preceding retrospective study, the percentage of patients within the target range after initiation of continuous vancomycin increased from 28% to 39% (excluding CRRT and ECMO patients) with calculated concentrations based on theoretical dose adjustments. In this study we want to prospectively evaluate the concentration of vancomycin at 24, 28 and 72 hours after the start of treatment with individualized dosages based on (a combination) of available PPK models in 134 adult ICU and orthopedic patients.

Conditions

Vancomycin; Pharmacokinetics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Starting dose of vancomycin standard vs MIPD

Comparison of vancomycin initial dosing via standard of care (flat dose adjusted for renal function) versus model informed precision dosing (starting dose adjusted using pharmacokinetic models).

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: DRUG

Initial dosing based on (a combinations of) pharmacokinetic models tailored to the individual patient. Dose adjustment starting dose (within registered dosing range).

Interventions

Vancomycin

Initial dosing based on (a combinations of) pharmacokinetic models tailored to the individual patient. Dose adjustment starting dose (within registered dosing range).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients who receive continuous vancomycin treatment at the ICU or orthopaedic department
• Patient or their legal representative is able and willing to sign the Informed Consent Form

Exclusion Criteria

• Pregnant woman
• Children
• Patients with a transplantation history
• Patients on continuous renal replacement therapy (CRRT)
• Patients receiving extracorporeal membrane oxygenation (ECMO)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sebastiaan D.T. Sassen, PharmD PhD

Pharmacometrician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

7646

Identifier Type: -

Identifier Source: org_study_id