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

Plain Language Summary

Simplified for easier understanding

Vancomycin is a critical antibiotic used to treat severe infections in people who are critically ill in intensive care. Getting the dose right is essential — too low and the infection isn't controlled; too high and it can damage the kidneys. Currently, blood tests are taken at regular intervals to monitor drug levels, which can be uncomfortable and inconvenient. This pilot study is testing a wearable sensor device (Nutromics) that continuously measures vancomycin levels through the fluid just under the skin (interstitial fluid), rather than through blood draws. Up to 100 ICU patients receiving vancomycin will wear the device throughout their treatment course. Researchers will compare the device's readings with standard blood test results to see how accurate it is. You may be eligible if you are an adult (aged 18–80) admitted to an ICU, have been prescribed intravenous vancomycin, and have a central or arterial catheter in place. People with skin conditions, allergies to metals or adhesives, or those who are pregnant are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.