Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000115437
Ethics application status
Approved
Date submitted
13/01/2025
Date registered
31/01/2025
Date last updated
13/04/2025
Date data sharing statement initially provided
31/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Sub-Protocol #1 of Umbrella Protocol Study: Limit of Blank Characterization of Vancomycin Biosensor Nutromics Device.
Scientific title
Sub-Protocol #1 of Umbrella Protocol Study: Limit of Blank Characterization of Vancomycin Biosensor Nutromics Device.
Secondary ID [1] 313624 0
NCRC-AU-2024/003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Therapeutic Drug Monitoring 336183 0
Condition category
Condition code
Infection 332722 332722 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective study with an Umbrella Protocol; where each sub-Protocol investigates a particular condition(s) and challenges to various Vancomycin biosensors and electrode properties. The study will enroll healthy participants in the community. Participants will be recruited for participation in stages depending on the Research and Development needs. This registration described Sub-Protocol #1.

The study will enroll no more than 50 participants. Participants may participate in more than one sub-Protocol of the Study, subject to their continued eligibility.

Potential participants will be recruited by flyers on community, university, and
Nutromics Operations noticeboards. Prospective participants will express interest via email to
[email protected].

Participants who have previously participated or expressed interested in studies at the Nutromics Clinical Research Centre may also be contacted and asked if they are interested in participating. Prospective participants will be sent an Online Health Screening. Nutromics employees can participate in this study.

Participants who meet the inclusion criteria (as per the Online Health Screening Survey) will be contacted for a brief phone screening for inclusion/exclusion criteria, including an explanation of the study details. A copy of the patient information sheet and consent form will be given to the participants who meet the inclusion criteria and still express interest in participating in the study following the phone discussion. Eligible participants who agree to participate in the study will be given time to consider their decision. Eligible participants who agree to participate in the study will be asked to attend an on-site Visit, where written consent will be obtained before any study procedures are conducted.

All on-site visits, and the procedures outlined below will be performed by the Clinical Research Coordinator (research nurse).

Sub-Protocol #1 Synopsis;
To assess Limit of Blank of the Nutromics Sensor Device regarding its the performance and stability over extended periods of wear. This includes evaluating any potential degradation in accuracy or precision of the measurements when the Nutromics Sensor Device is used continuously over a long duration.

Participants will arrive on-site and have two Nutromics Sensor Devices applied to the same upper arm. The Nutromics Sensor Device is wearable device that has four microneedles that enter just below the skin and are the biosensing component of the study. After completing all study visits procedures, participants will be allowed to leave the study site with the devices on their arm. Participants will return to the study site the following day (i.e. 24 hours later), where the Devices will be removed.

The schedule of events is outlined below.

On Site Visit
1.Written informed consent will be obtained .
Participants without childbearing potential will progress straight to Step #3
2.A pregnancy test will be conducted in all participants with childbearing potential and the result will be received prior to proceeding to Step #3.
3.Pathology test bloods (serum osmolality, Full Blood Count (FBC), Electrolytes, Urea and Creatinine (UEC), Liver Function Tests (LFT) and C-Reactive Protein (CRP)) are collected immediately prior to application of Nutromics Sensor Devices.
4.Application of two Nutromics Sensor Devices on the same upper arm following blood collection (+15 min).
5.Participants will complete an assessment post application (+15 min) of the Nutromics Sensor Devices to assess the pain associated with application of the devices .
6.Participants will remain at the site for 1 hour (+15 min) post application of Nutromics Sensor Devices
7. Immediately prior to the participant leaving the site, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected
8.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. The Devices should not be submerged in water.
9.Participants will be instructed to avoid applying excessive force or pressure on the Nutromics Sensor Devices.
10. In the event the Nutromics Sensor Device(s) fall off, participants are instructed not re-apply the device.
11. Participants will return to the site between 22 - 24 hours post Nutromics Sensor Device application,
12.Immediately prior to the removal of the Nutromics Sensor Devices, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected (-15 min)
13.The Nutromics Sensor Devices are removed
14. 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.
15. The participant is observed for 15 minutes (+15 min) following removal of the Nutromics Sensor Devices, after which they are discharged from the study.
16. Participants will be asked to report (using an online system) any adverse events .
Intervention code [1] 330219 0
Early detection / Screening
Comparator / control treatment
NO Control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340250 0
To assess the Limit of Blank (LoB) of the Nutromics Sensor Device regarding its performance and stability over extended periods of wear. This includes evaluating any potential degradation in accuracy or precision of the measurements when the Nutromics Sensor Device is used continuously over a long duration.
Timepoint [1] 340250 0
Across wear period where the Nutromics Sensor Device will collect data on vancomycin concentrations in interstitial fluid every 5 minutes.
Primary outcome [2] 340249 0
Establish the highest reported concentration Limit of Blank (LoB) likely to be observed for a blank sample using the Nutromics Sensor Device.
Timepoint [2] 340249 0
24 hour wear period.
Secondary outcome [1] 443486 0
Characterise the impact of hydration on the LoB of Vancomycin biosensors (serum osmolality)
Timepoint [1] 443486 0
Blood will be collected at three occasions to assess serum osmolality; immediately prior to application of the Devices, immediately prior to the participant being discharged whilst wearing the Device, and immediately following the removal of the Device the following day,
Secondary outcome [2] 443477 0
Evaluate the variability and error associated with Vancomycin biosensors when the target analyte is not present.
Timepoint [2] 443477 0
Across wear period where the Nutromics Sensor Device will collect data on vancomycin concentrations in interstitial fluid every 5 minutes.
Secondary outcome [3] 443485 0
To evaluate the safety of the Nutromics sensor device.
Timepoint [3] 443485 0
Blood will be collected at three occasions to assess safety of the Nutromics Sensor Device; immediately prior to application of the Devices, immediately prior to the participant being discharged whilst wearing the Device, and immediately following the removal of the Device the following day. Images of the application site will be taken prior to the application and removal of the Device. A pain score is obtained from the participant no more than 15 minutes following application of each Nutromics Sensor Device. Adverse Events will be assessed across the wear time of the Device.

Eligibility
Key inclusion criteria
Participants self-declaring healthy without any disease, condition or syndrome or on any current prescription medical treatments (other than contraception medication)

Aged 18-60 years
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who are pregnant, lactating, planning to become pregnant, breastfeeding, or donating ova.

Participants who declare previous allergic reactions to metals, plastics, and adhesives.

Participants who have a history of fainting or experiencing vasovagal reactions during blood draws.

Non-English-speaking participants.

Participants with small children in their household, where the Investigator believes that the device falling off could pose a biohazard risk if a child were to pick it up (Sub-Protocol #1 only).

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
Recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
11/02/2025
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
3/02/2026
Actual
Sample size
Target
50
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318093 0
Commercial sector/Industry
Name [1] 318093 0
Nutromics Operations
Country [1] 318093 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nutromics Operations
Address
Country
Australia
Secondary sponsor category [1] 320449 0
None
Name [1] 320449 0
Address [1] 320449 0
Country [1] 320449 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316739 0
Nutromics Diagnostics HREC
Ethics committee address [1] 316739 0
Ethics committee country [1] 316739 0
Australia
Date submitted for ethics approval [1] 316739 0
05/12/2024
Approval date [1] 316739 0
11/02/2025
Ethics approval number [1] 316739 0

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

Contacts
Principal investigator
Name 138854 0
A/Prof Sophie Stocker
Address 138854 0
Rm No S303, Building No A15, The University of Sydney, NSW, 2006
Country 138854 0
Australia
Phone 138854 0
+61 427 490 796
Fax 138854 0
Email 138854 0
[email protected]
Contact person for public queries
Name 138855 0
Emily Birthisel
Address 138855 0
Nutromics; 420 Victoria Street, Brunswick VIC, Australia
Country 138855 0
Australia
Phone 138855 0
+61 450695551
Fax 138855 0
Email 138855 0
[email protected]
Contact person for scientific queries
Name 138856 0
Mark Friedel
Address 138856 0
Nutromics; 420 Victoria Street, Brunswick VIC, Australia
Country 138856 0
Australia
Phone 138856 0
+61432887350
Fax 138856 0
Email 138856 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.