RecruitingACTRN12625000208404

Continuous monitoring of Intensive Care Unit (ICU) and Cardiac Care Unit (CCU) patients’ vancomycin levels in interstitial fluid: a pilot characterization study of a new device

Continuous monitoring of Intensive Care Unit (ICU) and Cardiac Care Unit (CCU) adult patients’ vancomycin levels in interstitial fluid: a pilot characterization study of a new device

Sponsor

Nutromics Operations Pty Ltd

Enrollment

100 participants

Start Date

Apr 8, 2025

Study Type

Interventional

Conditions

Infectious Diseases

Summary

This study observes the vancomycin treatment (up to four days) for 100 critically ill patients who are prescribed the antibiotic in the ICU with the Nutromics Sensor Device. These patients will have blood sampling across their vancomycin treatment period, in line with their prescribed treatment regimen (intermittent or continuous dosing). This study will compare vancomycin concentrations measured in interstitial fluid with the Device to those measured in blood samples, and will characterize the performance (ie: stability and precision) of the Device.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Inclusion Criteria4

Age 18-80 years
Hospitalised adults admitted to intensive care unit when they are enrolled are enrolled in the study
Prescribed vancomycin treatment for intravenous administration
A central or arterial catheter, and / or a large-bore cannula.

Exclusion Criteria4

Participants who are currently receiving or have received any investigational drug/device within the last 10 days.
History of allergic reactions to metals, plastics and adhesives which, in the opinion of the Study Investigators, would increase the risk of having allergic reactions associated with Device.
Dermatological (or other) condition, or fragile skin which, in the opinion of the Investigators would prevent the application of the Nutromics Sensor Device
Participants are pregnant, lactating, planning to become pregnant, breastfeed, or donate ova.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

All procedures described in the protocol will be carried out by the study team, or ICU clinicians / nurses. As soon as possible prior to, or upon commencing their course of vancomycin, a Nutromics

All procedures described in the protocol will be carried out by the study team, or ICU clinicians / nurses. As soon as possible prior to, or upon commencing their course of vancomycin, a Nutromics Sensor Device will be applied to the upper arm of the patient by hand, where it adheres to the skin with a medical grade adhesive. Every 24 hours, a new Nutromics Sensor Device will be applied to the patient’s upper arm. Data is being constantly gathered while the Device is applied to the participant, and there may be more than one device applied at any one time. Patients will be applied a maximum four Devices (new device every 24 hours for a maximum of four days). Photographs will be taken pre and post Device application to assess for adverse events. The study procedures are specific to the participants vancomycin dosing regimen in the period. Patients may have different dosing regimens across their treatment period. These blood samples are separate to standard of care vancomycin blood concentrations. Intermittent vancomycin dosing: For each infusion blood samples (2mL) for the measurement of serum vancomycin concentration will be collected soon as feasible upon commencing the course of vancomycin, at the end of the infusion and then at 1, 2, 3, 4, 6, 8 and 10-hours post-the end of the infusion for the duration of the whole treatment period of patients (up to 4 days). Continuous vancomycin dosing: Blood samples (2mL) for the measurement of serum vancomycin concentration will be collected 2 hours after the syringe/infusion swap and 2 hours prior to the next syringe/infusion swap in each 24-hour period of observation.