First Time Right of Vancomycin

Sponsor

Erasmus Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05964114

Collaborator

(none)

134

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vancomycin Pharmacokinetics	Drug: Vancomycin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

134 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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).

Drug: Vancomycin

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

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Erasmus Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sebastiaan D.T. Sassen, PharmD PhD, Pharmacometrician, Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT05964114

Other Study ID Numbers:

7646

First Posted:

Jul 27, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Vancomycin

Study Results

No Results Posted as of Jul 27, 2023