First Time Right of Vancomycin

Prospective Individualization of the First Vancomycin Dose Using Population Pharmacokinetic Models.

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05964114

Enrollment

134

Registered

2023-07-27

Start date

2023-10-31

Completion date

2026-06-30

Last updated

2023-07-27

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

Conditions

Pharmacokinetics, Vancomycin

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.

Interventions

DRUGVancomycin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of patients within target range of vancomycin for standard treatment versus treatment using MIPD within the first three days of treatment.	two years	The percentage of patients with a vancomycin concentration within the therapeutic range (20-25 mg/L) in the first three days after start of treatment for standard of care (flat dose adjusted for renal function) versus MIPD dosing (starting dose determined using pharmacokinetic models).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026