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Trial registered on ANZCTR


Registration number
ACTRN12625000208404p
Ethics application status
Submitted, not yet approved
Date submitted
17/01/2025
Date registered
21/02/2025
Date last updated
21/02/2025
Date data sharing statement initially provided
21/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 313731 0
MH-AU-2024/006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infectious Diseases 336339 0
Condition category
Condition code
Infection 332874 332874 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330328 0
Treatment: Devices
Comparator / control treatment
All participants in this study will have their standard of care unchanged, however all participants will also have Nutromics Sensor Device(s) applied, and additional blood draws taken. In the study, the vancomycin concentrations via the blood draws (per their treatment regimen described below) and of their interstitial fluid will be compared:

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.
Control group
Active

Outcomes
Primary outcome [1] 340400 0
Determine vancomycin concentrations in interstitial fluid
Timepoint [1] 340400 0
Continuously monitored throughout duration of wear time for each Device, and assessed following conclusion of patient participant (at the conclusion of their vancomycin treatment, up to four days of observation.
Primary outcome [2] 340401 0
Determine serum vancomycin concentrations
Timepoint [2] 340401 0
For intermittent vancomycin dosed participants: 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). For continuous vancomycin dosed participants: 2 hours after the syringe/infusion swap and 2 hours prior to the next syringe/infusion swap in each 24-hour period of observation.
Primary outcome [3] 340402 0
Characterize the performance (composite primary outcome) of the Nutromics Sensor Device
Timepoint [3] 340402 0
Continuously monitored throughout duration of wear time for each Devic, and assessed following conclusion of patient participant (at the conclusion of their vancomycin treatment, up to four days of observation.
Secondary outcome [1] 443963 0
To characterise the stability and precision of the Nutromics Sensor Device over time. This will be assessed as composite outcome.
Timepoint [1] 443963 0
Data analysed from vancomcyin being continuously monitored throughout duration of wear time for each Device, and assessed following conclusion of patient participant (at the conclusion of their vancomycin treatment, up to four days of observation.
Secondary outcome [2] 443964 0
To characterise the safety of the Nutromics Sensor Device
Timepoint [2] 443964 0
Continuously monitored throughout duration of wear time for each Device, and assessed following conclusion of patient participant (at the conclusion of their vancomycin treatment, up to four days of observation.
Secondary outcome [3] 443966 0
Efficacy of Vancomycin treatment
Timepoint [3] 443966 0
Outcomes of the 30 days following their completion of participation from the study; A patient’s participation in the study when the final Nutromics Sensor Device battery dies and is removed after either (whichever comes sooner): (1) Upon completion of their vancomycin treatment (2) After 4 days of observation with the Device (3) When they are discharged from the ICU or CCU

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318198 0
Commercial sector/Industry
Name [1] 318198 0
Nutromics Operations Pty Ltd
Country [1] 318198 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nutromics Operations Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320586 0
None
Name [1] 320586 0
Address [1] 320586 0
Country [1] 320586 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316849 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 316849 0
Ethics committee country [1] 316849 0
Australia
Date submitted for ethics approval [1] 316849 0
24/11/2024
Approval date [1] 316849 0
Ethics approval number [1] 316849 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139194 0
Prof Yahya Shehabi
Address 139194 0
Monash Health: 246 Clayton Road, Clayton 3168 VIC
Country 139194 0
Australia
Phone 139194 0
+61419296986
Fax 139194 0
Email 139194 0
yahya.shehabi@monashhealth.org
Contact person for public queries
Name 139195 0
Yahya Shehabi
Address 139195 0
Monash Health: 246 Clayton Road, Clayton 3168 VIC
Country 139195 0
Australia
Phone 139195 0
+61419296986
Fax 139195 0
Email 139195 0
yahya.shehabi@monashhealth.org
Contact person for scientific queries
Name 139196 0
Emily Birthisel
Address 139196 0
Nutromics: 420 Victoria St, Brunswick 3056 VIC
Country 139196 0
Australia
Phone 139196 0
+61450695551
Fax 139196 0
Email 139196 0
emily.birthisel@nutromics.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.