Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000280707
Ethics application status
Approved
Date submitted
21/12/2021
Date registered
15/02/2022
Date last updated
3/11/2024
Date data sharing statement initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of the Nutromics Sensor Device for the determination of Vancomycin concentrations and to evaluate biosensor safety.
Scientific title
Use of the Nutromics Sensor Device for the quantification of clinical targets to evaluate the safety of the Nutromics Sensor Device and to determine vancomycin concentrations in interstitial fluid using the Nutromics Sensor Device in healthy adults.
Secondary ID [1] 306003 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Therapeutic Drug Monitoring (TDM) 325192 0
Condition category
Condition code
Infection 322080 322080 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Nutromics Biosensor collects raw electrochemical data through DNA sensor on minimally invasive needles piercing the skin (~1mm) for the continuous monitoring and quantitative estimation of the drug Vancomycin concentrations in ISF.

Stage 1
• Review of medical condition and any changes in medications.
• Pregnancy test (blood) - for female participants with childbearing potential only.
• A sensor will be placed onto the participant’s upper arm. The time of sensor application will be recorded. After the sensor has been applied for 8 h (±15 min), the sensor will be removed.
• Blood samples for relevant pathology tests will be collected 10 to 30 minutes before sensor application, at 4 h (±15 min) post-application and 10 to 30 minutes post-removal of the sensor.
• Digitally captured images/recordings of the skin surface at the sensor application site; before and after the application and removal of the sensor to assess any skin irritation. Care will be taken to avoid capturing identifiable features of the participant.
• Participants will be required to complete a pain scale survey 5-10 minutes post-application and 5-10 minutes after removal of the sensor
• Participants will be required to conduct a physical challenge post-application of the sensor.
• 5-10 minutes prior to removal of the sensor, a mobility survey will be completed
• Participants will be monitored throughout the study duration for any adverse events. Participants will be observed for at least 15 minutes post removal of the sensors.


Stage 3a
• Participants will be asked to attend the study site and the following procedures will be conducted:
• Review of medical condition and any changes in medications.
• Pregnancy test (blood) - for female participants with childbearing potential only.
• 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.
• A sensor will be placed onto the participant’s upper arm opposite the arm where the vancomycin is being infused. The time of sensor application will be recorded. Sensor application will be 30 minutes (+15 min) prior to administering the vancomycin infusion and the sensor will be removed 10 h (±15 min) post-cessation of the infusion.
• Blood samples for relevant pathology tests (FBC, UEC and LFT) will be collected (10 to 30 minutes prior to application of the sensor and 10 to 30 minutes post-removal of the sensor. If the participant consented to providing blood samples for future research, these are to be collected prior to the placement of the sensor, or once the sensor has been removed, at the time most convenient for the Clinical Team.
• 30 minutes (+15 min) post-application of the sensor, the participant will receive a single dose of vancomycin as an intravenous infusion (1 gram over 1 hour 40 minutes). The time of administration and completion of infusion will be recorded.
• Blood samples for the measurement of vancomycin concentrations will be collected prior to the administration of vancomycin infusion, 30 min (±5 min) and 1 h (±10 min) during the infusion, at the end of the infusion (+15 min) and then at 40 min (±15 min), 1.5 h (±15 min), 2 h (±15 min), 3 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min) and 10 h (±15 min) after the infusion has been completed.
• Participants will be required to complete a pain scale survey 5-10 minutes post-application and 5-10 minutes after removal of the sensor
• Participants will be required to conduct a physical challenge post-application of the sensor.
• 5-10 minutes prior to removal of the sensor, a mobility survey will be completed.
• Digitally captured images/recordings of the skin surface at the sensor application site, before and after application and removal of the sensor, will be taken to assess any skin irritation. Care will be taken to avoid capturing identifiable features of the participant.
• Participants will be monitored throughout the study duration for any adverse events. Given the duration of this Study Visit, participants will be required to stay overnight. In the absence of any adverse events, participants will be discharged from the following morning after being observed for at least 15 minutes post removal of the sensors.

Stage 3b
• An intravenous cannula will be inserted in both left and right arms. One cannula will be used for administering intravenous vancomycin (n=3 participants with the cannula in their left arm and n=3 participants with the cannula in their right arm) and the cannula in the opposite arm is for blood sample collection.
- The first sensor will be applied onto one of the participant’s upper arms. Sensor will be applied 30 minutes (+15 min) prior to administering the first vancomycin infusion and removed up to 10 h post-cessation of the second vancomycin infusion (all sensors will be removed up to 24 hours after the application of the first pair of sensors)
- Blood samples for relevant pathology tests (FBC, UEC and LFT) will be collected 10 to 30 minutes prior to application of each sensor.
- If the participant consented to providing blood samples for future research, these are to be collected prior to the placement of the sensor, or once the sensor has been removed
- 30 minutes (+15 min) post-application of the sensor, the participant will receive two intravenous vancomycin doses (each dose 1 gram) administered 12 hours apart (start to start). Each intravenous vancomycin dose will be infused over 1 hour 40 minutes. The time of administration and completion of each infusion will be recorded.
- Blood samples for the measurement of vancomycin concentrations will be collected before the administration of the first vancomycin infusion, 30 min (±5 min) and 1 h (±10 min) during the infusion, at the end of the infusion (+15 min) and then at 40 min (±15 min), 1.5 h (±15 min), 2 h (±15 min), 3 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min) and, 10 h (±15 min) after the infusion has been completed.
- A second sensor will be placed 10 h (±15 min) after the beginning of the first vancomycin infusion The additional sensor will be placed on to the other participants’ upper arm (such that there is one Nutromics Sensor Device on each of the partcipants upper arms). The sensor that was originally placed on the participant’s upper arm will also remain applied

- Blood samples for relevant pathology tests (FBC, UEC and LFT) will be collected 10 to 30 minutes post-removal of both the first and second sensors.
- Blood samples for the measurement of vancomycin concentrations will be collected 5-10 minutes before commencing the second vancomycin infusion, at 30 min (±5 min) and 1 h (±10 min) during the infusion, as well as at the end of the infusion (+15 min) and then at 40 min (±15 min), 1.5 h (±15 min), 2 h (±15 min), 3 h (±15 min), 4 h (±15 min), 6 h (±15 min) and 8 h (±15 min) after the infusion has been completed.
- Participants will be required to complete a pain scale survey 5-10 minutes post-application of each sensor and 5-10 minutes after removal of the sensor
- Participants will be required to conduct a physical challenge post-application of each sensor.
- 5-10 minutes before the second Nutromics Sensor Device is applied, and 5-10 minutes prior to removal both sensors, a mobility survey will be completed.
- Digitally captured images/recordings of the skin surface at the sensor application site after removal of each sensor

Stage 3c
- An intravenous cannula will be inserted in both left and right arms. One cannula will be used for administering intravenous and the cannula in the opposite arm is for blood sample collection.
- Blood samples for relevant pathology tests be collected 10 to 30 minutes prior to application of the sensor will and 10 to 30 minutes post-removal of the sensor
- Pregnancy test (blood) – for female participants with child bearing potential only.
- Four Nutromics Sensor Devices will be applied; two will be placed on the upper arm of the participant (same arm), one will be placed on the abdomen and the fourth will be applied to either of the participant’s lower leg. A fifth Nutromics Sensor Device will be applied to the opposite forearm 12 hours after the first set of devices were applied.
- All sensors will remove up to 24 hours after the application of the first set of sensors
- The participant will receive two vancomycin doses (each dose: 700 mg) administered intravenously. Each Vancomycin dose will commence 1 hour and 30 minutes following the application each set of Nutromics Sensor Devices. The vancomycin infusions will be administered 12 hours apart (start-to-start). Each intravenous vancomycin dose will be infused over 1 hour 10 minutes.
- Blood samples will be collected prior to the administration of the first vancomycin infusion, 30 min (±5 min) during the infusion, at the end of the infusion (+15 min), and then at 40 min (±15 min), 1.5 h (±15 min), 2 h (±15 min), 3 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min) and 10 h (±15 min) after the infusion has been completed.
- Blood samples will be collected at 30 min (±5 min) during the infusion, the end of the second vancomycin infusion (+15 min) and then at 40 min (±15 min), 1.5 h (±15 min), 2 h (±15 min), 3 h (±15 min), 4 h (±15 min), 6 h (±15 min), and 8 h (±15 min) after the infusion has been completed.
- Before and after the application and removal of the sensor, photographs/recordings of the skin surface at the sensor application site
- Participants will be required to complete a pain scale survey 5-10 minutes post-application of each set of sensors and 5-10 minutes after removal of all the sensors
- Participants will be required to conduct a physical challenge post-placement of each set of sensors.
- 5-10 minutes prior to removal of the sensors, a mobility survey will be completed
Intervention code [1] 322406 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329875 0
To evaluate the safety of the Nutromics Sensor Device by: •Monitoring full blood count (FBC), urea electrolytes creatinine (UEC), and liver function test (LFT) results, pre-application and post-removal of the sensor to be within normal or biological variation. •Examining digitally captured images/recordings of the skin surface at the sensor application site(s) for signs of irritation and allergic reactions.• Observing participants pain and mobility using the scales provided.• Assess adverse events.
Timepoint [1] 329875 0
Participants will be clinically evaluated and blood tests taken prior to study commencement, prior to an intervention, and post intervention, with follow up performed 14 days post last intervention. Questions regarding the monitoring and verbal confirmation of participant comfort during the study are included in the case report forms. Adverse events may be observed by the clinical team, become apparent from monitoring or testing performed, self reported by participants to the investigators or shared via medical records from the participants medical care team either during the study or some time after. Digital images are collected prior to insertion, post insertion, and after removal of the sensor to assist with this process.
Primary outcome [2] 329972 0
To determine vancomycin concentrations in interstitial fluid using the Nutromics Sensor Device.
Timepoint [2] 329972 0
For stage 3a, blood samples for the measurement of vancomycin concentrations will be
collected prior to the administration of vancomycin infusion, 30 min (±5 min)
and 1 h (±10 min) during the infusion, at the end of the infusion (+15 min) and
then at 40 min (±15 min), 1.5 h (±15 min), 2 h (±15 min), 3 h (±15 min), 4 h (±15
min), 6 h (±15 min), 8 h (±15 min) and 10 h (±15 min) after the infusion has been
completed, and will be compared to concentrations of vancomycin in interstitial fluid from the Nutromics Sensor Device.

For Stage 3b, blood samples for the measurement of vancomycin concentrations will be
collected before the administration of the first vancomycin infusion, 30 min
(±5 min) and 1 h (±10 min) during the infusion, at the end of the infusion (+15
min) and then at 40 min (±15 min), 1.5 h (±15 min), 2 h (±15 min), 3 h (±15 min), 4
h (±15 min), 6 h (±15 min), 8 h (±15 min) and, 10 h (±15 min) after the infusion has
been completed. Blood samples for the measurement of vancomycin concentrations will be collected 5-10 minutes before commencing the second vancomycin infusion,
at 30 min (±5 min) and 1 h (±10 min) during the infusion, as well as at the end of
the infusion (+15 min) and then at 40 min (±15 min), 1.5 h (±15 min), 2 h (±15 min),
3 h (±15 min), 4 h (±15 min), 6 h (±15 min) and 8 h (±15 min) after the infusion has
been completed and will be compared to concentrations of vancomycin in interstitial fluid from the Nutromics Sensor Device.
Secondary outcome [1] 404124 0
To compare interstitial fluid vancomycin concentrations obtained by the sensor to those in plasma obtained by venous sampling following the administration of intravenous vancomycin (Stage 3).
Timepoint [1] 404124 0
Blood samples for the measurement of vancomycin concentrations will be collected prior to the administration of vancomycin infusion, 30 min (±5 min) and 1 h (±10 min) during the infusion, at the end of the infusion (+15 min) and then at 40 min (±15 min), 1.5 h (±15 min), 2 h (±15 min), 3 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min) and 10 h (±15 min) after the infusion has been completed (10 sampling time points) and will be compared to concentrations of vancomycin in interstitial fluid from the Nutromics Sensor Device.
Secondary outcome [2] 404126 0
To investigate the stability of the sensor readings and signal variability for vancomycin across 24 hours (Stage 3b).
Timepoint [2] 404126 0
Blood samples for the measurement of vancomycin concentrations will be collected before the administration of the first vancomycin infusion, 30 min (±5 min) and 1 h (±10 min) during the infusion, at the end of the infusion (+15 min) and then at 40 min (±15 min), 1.5 h (±15 min), 2 h (±15 min), 3 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min) and, 10 h (±15 min) after the infusion has been completed. Blood samples for relevant pathology tests (FBC, UEC and LFT) will be collected 10 to 30 minutes post-removal of both the first and second sensors. Blood samples for the measurement of vancomycin concentrations will be collected 5-10 minutes before commencing the second vancomycin infusion, at 30 min (±5 min) and 1 h (±10 min) during the infusion, as well as at the end of the infusion (+15 min) and then at 40 min (±15 min), 1.5 h (±15 min), 2 h (±15 min), 3 h (±15 min), 4 h (±15 min), 6 h (±15 min) and 8 h (±15 min) after the infusion has been completed.

Eligibility
Key inclusion criteria
-Age 18-60 years.
-Individuals without clinically significant medical abnormalities contraindicating participation as determined by Study Investigators, including, but not limited to:
a) Physical examination without any clinically relevant findings.
b) Systolic blood pressure in the range of 90 to 140 mmHg (inclusive) and diastolic blood pressure in the range of 50 to 90 mmHg (inclusive) after 5 minutes of rest in a supine position.
c) Pulse rate in the range of 60 to 100 bpm (inclusive) after 5 minutes of rest in a supine position. A 40-60 bpm (inclusive) may be considered acceptable for participants without clinically significant findings at the discretion of the Principal Investigator.
d) Body temperature (tympanic), between 35.5°C and 37.5°C (inclusive).
e) No clinically significant findings in serum biochemistry and haematology tests, and urinalysis contraindicating participation as determined by Study Investigators.

Female participants with childbearing potential must from the period of signing the consent form until at least 28 days after the removal of the sensor:
a) Have a negative pregnancy test at Screening and Study Visits.
b) Not planning to become pregnant.
c) Not be breastfeeding.
d) Not donate ova.
If engaging in sexual intercourse, they are required to use effective contraception during the study and strongly recommended to use effective contraception for at least 28 days after the removal of the sensor.

- Allow for digitally captured images and recordings of the skin surface at the sensor application site while maintaining participant anonymity.
- Participation is not influenced by vaccination status. However, participants who have been vaccinated within one week of the Study visit will not be recruited.
- Willingness to provide written informed consent and comply with the study protocol.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Poor venous access for venepuncture
Participants who are currently receiving or have received any investigational drug/device within the last 30 days.
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, vancomycin administration.
Active illnesses
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.

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2022
Actual
2/11/2022
Date of last participant enrolment
Anticipated
Actual
29/05/2024
Date of last data collection
Anticipated
Actual
19/06/2024
Sample size
Target
27
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23556 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 38978 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 310346 0
Commercial sector/Industry
Name [1] 310346 0
Nutromics IP Pty Ltd
Country [1] 310346 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nutromics IP Pty Ltd
Address
420 Victoria Street, Brunswick, Victoria 3056
Country
Australia
Secondary sponsor category [1] 311501 0
None
Name [1] 311501 0
Address [1] 311501 0
Country [1] 311501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310325 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 310325 0
Ethics committee country [1] 310325 0
Australia
Date submitted for ethics approval [1] 310325 0
17/11/2021
Approval date [1] 310325 0
21/12/2021
Ethics approval number [1] 310325 0

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

Contacts
Principal investigator
Name 116142 0
A/Prof Stephen Pianko
Address 116142 0
Monash Health, VIC 246 Clayton Rd, Clayton, VIC 3168
Country 116142 0
Australia
Phone 116142 0
+6138572 2565
Fax 116142 0
Email 116142 0
Stephen.Pianko@monashhealth.org
Contact person for public queries
Name 116143 0
Emily Birthisel
Address 116143 0
Nutromics IP Pty Ltd, 420 Victoria Street, Brunswick, VIC 3056
Country 116143 0
Australia
Phone 116143 0
+61450695551
Fax 116143 0
Email 116143 0
emily.birthisel@nutromics.com.au
Contact person for scientific queries
Name 116144 0
Emily Birthisel
Address 116144 0
Nutromics IP Pty Ltd, 420 Victoria Street, Brunswick, VIC 3056
Country 116144 0
Australia
Phone 116144 0
+61450695551
Fax 116144 0
Email 116144 0
emily.birthisel@nutromics.com.au

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.