First Time Right of Vancomycin

ConditionsVancomycin Pharmacokinetics

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorErasmus Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant woman

Children

Patients with a transplantation history

Patients on continuous renal replacement therapy (CRRT)

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

134 Participants

are divided into 1 treatment group

Group A: Starting dose of vancomycin standard vs MIPDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of patients within target range of vancomycin for standard treatment versus treatment using MIPD within the first three days of treatment.

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).

Time frame

two years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

Source ClinicalTrials.gov

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