First Time Right of Vancomycin

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05964114
• Other study ID #: 7646
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: June 2026

Study information

• Verified date: July 2023
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: June 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pharmacokinetics
• Vancomycin

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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