None listed
Conditions
Brief 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.
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 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
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.
Sponsors
Nutromics Operations Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
• 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 criteria
• 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.
Outcome results
None listed