First Time Right of Vancomycin

NCT05964114 | Not Yet Recruiting

• 1 other identifier: 7646
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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).

  two years

Study Arms (1)

Starting dose of vancomycin standard vs MIPD

EXPERIMENTAL

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).

Drug: Vancomycin

Interventions

Vancomycin DRUG

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

Starting dose of vancomycin standard vs MIPD

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacometrician

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: July 27, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 27, 2023

Record last verified: 2023-07