Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000478415p
Ethics application status
Submitted, not yet approved
Date submitted
13/04/2025
Date registered
19/05/2025
Date last updated
19/05/2025
Date data sharing statement initially provided
19/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
VANCORE: VANcomycin dosing study to CORrElate between compartments: a pilot characterisation study of a new device.
Scientific title
VANCORE: VANcomycin dosing study to CORrElate between compartments: a pilot characterisation study of a new device.
Secondary ID [1] 314175 0
NCRC-AU-2025/009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Therapeutic Drug Monitoring (TDM) 337027 0
Condition category
Condition code
Infection 333480 333480 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single dose, open-label, single cohort vancomycin dosing study.

The Nutromics Sensor Device is a single-use continuous diagnostic monitoring platform that contains 4 microneedles, with the purpose to acquire raw electrochemical data. The microneedles have been developed (by Nutromics) to contain single-strand DNA receptors (called "Aptamers") that are engineered to specifically detect the concentration of Vancomycin (as of current) within the interstitial fluid from the skin. The Nutromics Sensor Device will apply the participant's skin with adhesive.

Each participant will progress through all stages of the study and receive each dose of vancomycin, of each stage on a separate day. Participants will receive the following vancomycin doses:
• Stage 1: 500 mg
• Stage 2: 2000 mg
• Stage 3: 1500 mg
• Stage 4: 1000 mg

The device itself will be contained in a plastic frame with a removal adhesive liner covering the side containing the microneedles. The white adhesive liner will be removed and the now adhesive side of the device, will then be applied to the participant's upper arm with firm pressure (the area on the arm will be cleaned prior to application using alcohol wipe). As the outside of the device is still covered by the plastic frame, this will then be removed, exposing the exterior side of the device. A light is expected to be visible from the exterior of the device. Finally, firmly press the device (indicated by the circular frosted logo) inward against the upper arm until an audible click is heard, confirming that it has now been correctly placed. If the device falls off before use, it should be appropriately discarded. However, if device falls off after application, it will need to be repackaged for return.

Participants will be required to visit the Study Site on at least nine occasions. There should be no more than 7 days between the Screening and Dosing Visits. The study is designed to administer each dose stage sequentially using the same device configuration. Participants will be pre-scheduled for all visits at the time of enrolment to ensure attendance. If a participant is unavailable for a scheduled visit and more than 10 days (±3 days) pass between on-site visits, they will be required to undergo an additional screening visit before proceeding. The minimum number of days between Dosing Visits is 3 days.

Stages may happen in parallel, but each participant must complete the stages of Dosing Visits sequentially.

Screening Visit (Duration: ~2 hours)
At the Screening Visit, a member of the Study Team will explain the details of the study and upon provision of written informed consent, the participant will undergo the following procedures:

• Collection of demographic information (birth date, sex, race, and ethnicity).
• Medical history review;
• Review of current medications, including herbal medicines, supplements, and vitamins;
• Measurement of height and body weight.
• Blood sample collection for relevant pathology tests.

If the assessment results confirm eligibility of the participant [and if the participant consents to participate in the study], the participant will be asked to return to the Nutromics Clinical Research Centre for a Study Visit as outlined below. If the participant does not meet the eligibility criteria for this study, the reason(s) for this decision will be explained to the participant by a Study Investigator.

Dosing Visit (Duration: ~24 hours)
Participants will remain for the duration of the Dosing Visit and be continuously monitored for adverse events by site staff. Participants will be under the care of study site staff during their stay at the study site for their dosing visit. Participants will be able to go to the toilet and move around. Participants will be required to not leave the Study Site.

Assessments are as follows:

• Review of medical condition and any changes in medications. A blood test will be taken to test for pregnancy in Females of childbearing potential.
• An intravenous cannula will be inserted in both left and right arms. One cannula will be used for administering intravenous vancomycin and the other cannula is for blood sample collection.
• Blood samples for relevant pathology tests be collected 30 (±15 min) minutes prior to application of the first set of Nutromics Sensor Devices.
• Four Nutromics Sensor Devices will be applied to the participant; two on each upper arm.
• The participant will complete a Pain Survey following the application of Nutromics Sensor Devices (+ 5 min).
• 1.5 hours following the application of the Nutromics Sensor Devices, participants will be administered the applicable dose of vancomycin intravenously.
• Blood samples for vancomycin concentration testing will be collected:
o prior to the administration of the vancomycin infusion
o halfway through the infusion time,
o at the end of the infusion (+15 min)
o 40 min (±15 min) following the end of the infusion.
o 1.5 h (±15 min) following the end of the infusion
o 2 h (±15 min) following the end of the infusion.
o 3 h (±15 min) following the end of the infusion.
o 4 h (±15 min) following the end of the infusion.
o 6 h (±15 min) following the end of the infusion.
o 8 h (±15 min) following the end of the infusion.
o 10 h (±15 min) following the end of the infusion (Stages 1,3 and 4 only)
• 14 (±30 min) hours following the application of the Devices, the participant will be discharged from the study site
• Immediately prior to the participant leaving the site, pathology test bloods will be collected, after which the cannulas will be removed.
• Participants may perform their normal daily activities including sports, showering, etc.; and the type of activity, start and end time of these activities shall be recorded by the participant ((2)on an activity monitoring log provided to the participant before being discharged for each dosing visit).
The Devices should not be submerged in water.
• Participants will be instructed to avoid apply excessive force or pressure on the Nutromics Sensor Devices.
• In the event the Nutromics Sensor Device(s) fall off, participants are instructed not re-apply the device.
• Participants will return to the site between 22 - 24 hours post Nutromics Sensor Device application,
• Immediately prior to the removal of the Nutromics Sensor Devices, pathology test bloods (vancomycin, serum osmolality, FBC, UEC, LFT and CRP) will be collected (-15 min)
• The Nutromics Sensor Devices are removed
• Images are taken of the application sites for each of the Nutromics Sensor Device following their removal. Care will be taken to avoid identifiable features
• The participant is observed for 15 minutes (+15 min) following removal of the Nutromics Sensor Devices, after which they are discharged from the study.
Intervention code [1] 330775 0
Treatment: Devices
Comparator / control treatment
Dose comparison between same 12 participants, dosed four separate vancomycin doses in a staged manner.
Control group
Dose comparison

Outcomes
Primary outcome [1] 341054 0
To establish the correlation of the Area Under the Curve (AUC) of vancomycin between serum and interstitial fluid (ISF).
Timepoint [1] 341054 0
Blood samples for vancomycin concentration testing will be collected: o prior to the administration of the vancomycin infusion o halfway through the infusion time, o at the end of the infusion (+15 min) o 40 min (±15 min) following the end of the infusion. o 1.5 h (±15 min) following the end of the infusion o 2 h (±15 min) following the end of the infusion. o 3 h (±15 min) following the end of the infusion. o 4 h (±15 min) following the end of the infusion. o 6 h (±15 min) following the end of the infusion. o 8 h (±15 min) following the end of the infusion. o 10 h (±15 min) following the end of the infusion (Stages 1,3 and 4 only) Vancomycin concentrations with the Nutromics Sensor Device will be collected every 5 minutes throughout wear time.
Secondary outcome [1] 445988 0
Vancomycin concentrations in blood serum samples.
Timepoint [1] 445988 0
Blood samples for vancomycin concentration testing will be collected: o prior to the administration of the vancomycin infusion o halfway through the infusion time, o at the end of the infusion (+15 min) o 40 min (±15 min) following the end of the infusion. o 1.5 h (±15 min) following the end of the infusion o 2 h (±15 min) following the end of the infusion. o 3 h (±15 min) following the end of the infusion. o 4 h (±15 min) following the end of the infusion. o 6 h (±15 min) following the end of the infusion. o 8 h (±15 min) following the end of the infusion. o 10 h (±15 min) following the end of the infusion (Stages 1,3 and 4 only) Vancomycin concentrations with the Nutromics Sensor Device will be collected every 5 minutes throughout wear time.
Secondary outcome [2] 445989 0
Vancomycin concentrations in interstitial fluid
Timepoint [2] 445989 0
Blood samples for vancomycin concentration testing will be collected: o prior to the administration of the vancomycin infusion o halfway through the infusion time, o at the end of the infusion (+15 min) o 40 min (±15 min) following the end of the infusion. o 1.5 h (±15 min) following the end of the infusion o 2 h (±15 min) following the end of the infusion. o 3 h (±15 min) following the end of the infusion. o 4 h (±15 min) following the end of the infusion. o 6 h (±15 min) following the end of the infusion. o 8 h (±15 min) following the end of the infusion. o 10 h (±15 min) following the end of the infusion (Stages 1,3 and 4 only) Vancomycin concentrations with the Nutromics Sensor Device will be collected every 5 minutes throughout wear time.
Secondary outcome [3] 445990 0
• To evaluate the safety of the Nutromics Sensor Device
Timepoint [3] 445990 0
Throughout wear time.

Eligibility
Key inclusion criteria
• Age 18-60 years.
• ‘Healthy’ individuals without clinically significant medical abnormalities contraindicating participation as determined by Study Investigators, including, but not limited to:
• No clinically significant findings in vital signs, serum biochemistry or haematology tests contraindicating participation as determined by Study Investigators.
• Female participants of childbearing potential must;
• Have a negative pregnancy test at Screening Visit and Overnight Visits.
• Not planning to become pregnant for the duration of the study.
• Not be breastfeeding for the duration of the study.
• Not donate ova for the duration of the study.
• Participants with a calculated Creatinine Clearance (CrCl) as described by the Australian Medicines Handbook of greater than, or equal to 90mL/min.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Participants are pregnant, lactating, planning to become pregnant, breastfeed, or donate ova.
• History of allergic reactions to vancomycin, metals, plastics and adhesives which, in the opinion of the Study Investigators, would increase the risk of having allergic reactions associated with skin allergies, or vancomycin administration
• Participants who are currently receiving, or have received, any other investigational drug/device within the last 30 days.
• Active illnesses ,that, in the opinion of the Study Investigators, may interfere with the completion of the study.
• Deafness or hearing issues
• Participants who have a history of fainting or experiencing vasovagal reactions during blood draws
• Deafness or hearing issues
• Consumption of prescription medications, except oral contraceptive pills
• Use of illicit drugs or alcohol consumption, which, in the opinion of the Study Investigators, may interfere with the completion of the study.
• Non-English-speaking participants
• Is an employee of Nutromics Operations Pty Ltd.

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
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
30/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318690 0
Commercial sector/Industry
Name [1] 318690 0
Nutromics Operations Pty Ltd
Country [1] 318690 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nutromics Operations Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 321120 0
None
Name [1] 321120 0
Address [1] 321120 0
Country [1] 321120 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317301 0
Nutromics Diagnostics HREC
Ethics committee address [1] 317301 0
Ethics committee country [1] 317301 0
Australia
Date submitted for ethics approval [1] 317301 0
24/04/2025
Approval date [1] 317301 0
Ethics approval number [1] 317301 0

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

Contacts
Principal investigator
Name 140618 0
Prof Carl Kirkpatrick
Address 140618 0
Monash University Parkville Campus, 381 Royal Parade, Parkville Victoria 3052
Country 140618 0
Australia
Phone 140618 0
+61410158058
Fax 140618 0
Email 140618 0
[email protected]
Contact person for public queries
Name 140619 0
Carl Kirkpatrick
Address 140619 0
Monash University Parkville Campus, 381 Royal Parade, Parkville Victoria 3052
Country 140619 0
Australia
Phone 140619 0
+61410158058
Fax 140619 0
Email 140619 0
[email protected]
Contact person for scientific queries
Name 140620 0
Carl Kirkpatrick
Address 140620 0
Monash University Parkville Campus, 381 Royal Parade, Parkville Victoria 3052
Country 140620 0
Australia
Phone 140620 0
+61410158058
Fax 140620 0
Email 140620 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.