Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000130460
Ethics application status
Approved
Date submitted
13/12/2024
Date registered
5/02/2025
Date last updated
5/02/2025
Date data sharing statement initially provided
5/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous monitoring of Intensive Care Unit (ICU) patients’ vancomycin levels in interstitial fluid: a pilot feasibility study of a new device
Scientific title
Continuous monitoring of Intensive Care Unit (ICU) adult patients’ vancomycin levels in interstitial fluid: a pilot feasibility study of a new device
Secondary ID [1] 313571 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection 336089 0
Condition category
Condition code
Infection 332647 332647 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1: Adults in ICU prescribed vancomycin will be invited to participate in the study. Participants can be enrolled if their guardian provides consent prior to applying the device. These participants will be approached at a later stage to obtain consent to continue to participate in the study. Consenting participants will have the device applied to the skin (e.g. upper arm) as soon as feasible upon commencing the course of vancomycin. This device will remain in place for 24 hours. A second device will be applied to the skin (e.g. upper arm) 11-12 hours after application of the first device. The second device will remain in place for 12 hours. Both devices are the same Nutromics Sensor Device, meaning, two of the same Nutromics Sensor Device will be applied, one for 24 hours and the other for 12 hours. Photographs will be taken pre and post Device application to assess for adverse events. This process will be repeated on a second occasion.

Participants with Intermittent Vancomycin Dosing Regimens:
Blood samples (4 mL) will be collected during a dosing interval. Blood samples for the measurement of plasma vancomycin concentration will be collected prior to the administration of the vancomycin infusion in each 24 hour observation period, at the end of the infusion and then at 1, 2, 3, 4, 6, 8 and 10-hours post-the end of each infusion. In addition, any vancomycin concentrations obtained as part of standard care will be recorded. Inflammatory markers (e.g. CRP) will also be tested at the 1 and 10 hour time points for each 24 hour observation period. This blood sampling schedule will be repeated on a second occasion in conjunction with the application of the devices.

Participants with Continuous Vancomycin Dosing Regimens:
Blood samples (4 mL) will be collected during a continuous infusion. Blood samples for the measurement of plasma vancomycin concentration will be collected 2 hours after the syringe/infusion swap and 2 hours prior to the next syringe/infusion swap. In addition, any vancomycin concentrations obtained as part of standard care will be recorded. Inflammatory markers (e.g. CRP) will also be tested at these time points for each 24-hour observation period. This blood sampling schedule will be repeated on a second occasion in conjunction with the application of the devices.

The first Nutromics Sensor Device applied to the patient in the 24 hour observational period will remain on the upper arm of the patient for 24 hours, and the second Device applied 12 hours into the period of observation will remain applied for 12 hours. The Devices are single use, to be applied by a healthcare professional, and have been shown to be relatively painless and have no impact on mobility. Participating in this study will have no impact on their prescribed care or vancomycin therapy.

Part 2: After having provided written informed consent an in-depth survey will be conducted with healthcare professionals, including prescribers, nurses and pharmacists, involved in using the device (Part 1) to better understand feasibility, potential utility and impact on practice. Survey questions will focus on current practice and their role in using the device during Part 1. Participants will be asked to comment on the process (feasibility) of integrating the device into routine critical care medicine and any suggestions for improvements.
Intervention code [1] 330167 0
Treatment: Devices
Comparator / control treatment
Standard care - blood sampling to determine vancomycin concentration.

Control group
Active

Outcomes
Primary outcome [1] 340146 0
Determination of interstitial fluid vancomycin concentrations
Timepoint [1] 340146 0
Continuous monitoring for each 24-hour observation period.
Primary outcome [2] 340372 0
Determination of plasma vancomycin concentrations
Timepoint [2] 340372 0
Blood is taken: - prior to the administration of each vancomycin infusion, then at the end of the infusion and then at 1, 2, 3, 4, 6, 8 and 10-hours post-end of the infusion (if patient on intermittent vancomycin regimen), OR - 2 hours after the syringe/infusion swap and 2 hours prior then next syringe/infusion swap (if patient on continuous vancomycin therapy).
Secondary outcome [1] 442980 0
Efficacy of vancomycin treatment
Timepoint [1] 442980 0
30 days post cessation of the course of therapy.
Secondary outcome [2] 442981 0
To characterise the safety of the Device, including adverse events, used to determine interstitial fluid concentrations of vancomycin in ICU participants.
Timepoint [2] 442981 0
Photographs taken immediately prior to application and within 5 minutes of removal of the Nutromics Sensor Devices. Inflammatory markers will be tested at the 1- and 10-hour timepoints for each 24-hour observation period. Adverse events reported within 24 hours of observation by the study team, patient/guardian or treating clinicians.
Secondary outcome [3] 443896 0
Safety of vancomycin treatment
Timepoint [3] 443896 0
30 days post cessation of the course of therapy.
Secondary outcome [4] 442983 0
Understand perceptions of healthcare professionals (including doctors and nurses) of the utility and impact on workflows of using the device to inform vancomycin dosing decisions. This will be assessed as a composite outcome.
Timepoint [4] 442983 0
The survey will take place after the completion of part 1; once all 30-day post treatment outcomes have been collected.
Secondary outcome [5] 443897 0
Pharmacokinetics (AUC 12/24, Cmax, Tmax and T1/2) of vancomycin in interstitial fluid
Timepoint [5] 443897 0
Interstitial fluid concentrations continuously measured by the Device over 24 hour period
Secondary outcome [6] 442982 0
Pharmacokinetics (AUC 12/24, Cmax, Tmax and T1/2) of vancomycin in plasma
Timepoint [6] 442982 0
Blood taken: - prior to the administration of each vancomycin infusion, then at the end of the infusion and then at 1, 2, 3, 4, 6, 8 and 10-hours post-end of the infusion (if patient on intermittent vancomycin regimen), OR 2 hours after the syringe/infusion swap and 2 hours prior then next syringe/infusion swap (if patient on continuous vancomycin therapy).

Eligibility
Key inclusion criteria
Part 1:
• Age 18-80 years
• Hospitalised adults admitted to intensive care unit
• Prescribed vancomycin treatment administered intravenously (intermittent or continuous administration) by attending medical team irrespective of the duration of therapy
• Written informed consent (or of their authorised representative/guardian)
• Arterial or venous access

Part 2:
• Intensive care healthcare professionals, including prescribers (senior and junior), nurses and pharmacists, involved in the use of the Device.
• Written informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Part 1:
• Participants who are currently receiving or have received any investigational drug/device within the last 10 days.
• Participants with a 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.
• Participants with dermatological (or other) condition preventing application of Device.
• Participants who are pregnant or lactating.

Part 2:
• None

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
Other design features
All participants will continue to receive their standard care but have the Nutromics Sensor Device(s) applied and have additional blood draws. Blood is taken:
- prior to the administration of each vancomycin infusion, then at the end of the infusion and then at 1, 2, 3, 4, 6, 8 and 10-hours post-end of the infusion (if patient on intermittent vancomycin regimen), OR
- 2 hours after the syringe/infusion swap and 2 hours prior then next syringe/infusion swap (if patient on continuous vancomycin therapy).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Part 1: The total number of participants is expected to be 40. The sample size is based on similar approaches used to compare bioanalytical methods, where 40-100 samples (i.e. AUC values) are suggested. Approximately 40 participants are required to provide 120 samples.

The vancomycin concentration-time profile will be plotted and the area under the concentration-time curve (AUC) over a dosing interval (12 or 24 hours) will be compared across the two matrices (interstitial fluid vs plasma). Additional pharmacokinetic parameters (e.g. peak concentration, time to peak concentration) will be determined and compared across the matrices. A mathematical model (physiological based pharmacokinetic model) will be developed to describe the pharmacokinetics of vancomycin in both plasma and interstitial fluid.

Descriptive statistics and correlation analysis will be used to characterise the relationship between vancomycin exposure based on continuous monitoring and efficacy and safety outcomes related to the course of vancomycin.

Part 2: Stakeholders involved in the use of the Device and care of ICU patients will be recruited. The total number of healthcare professionals (physicians, pharmacists and nurses) is expected to be 15-20.

De-identified surveys will be analysed to identify themes. Investigators will meet periodically throughout data collection to discuss survey responses and themes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27417 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 43530 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 318036 0
Commercial sector/Industry
Name [1] 318036 0
Nutromics Pty Ltd
Country [1] 318036 0
Australia
Funding source category [2] 318035 0
Other
Name [2] 318035 0
Ramaciotti Health Investment Grant
Country [2] 318035 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320380 0
None
Name [1] 320380 0
Address [1] 320380 0
Country [1] 320380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316691 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316691 0
Ethics committee country [1] 316691 0
Australia
Date submitted for ethics approval [1] 316691 0
04/10/2024
Approval date [1] 316691 0
16/12/2024
Ethics approval number [1] 316691 0

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

Contacts
Principal investigator
Name 138682 0
A/Prof Sophie Stocker
Address 138682 0
Rm No S303, Building No A15, The University of Sydney,NSW 2006
Country 138682 0
Australia
Phone 138682 0
+61 427 490 796
Fax 138682 0
Email 138682 0
[email protected]
Contact person for public queries
Name 138683 0
Sophie Stocker
Address 138683 0
Rm No S303, Building No A15, The University of Sydney,NSW 2006
Country 138683 0
Australia
Phone 138683 0
+61 427 490 796
Fax 138683 0
Email 138683 0
[email protected]
Contact person for scientific queries
Name 138684 0
Sophie Stocker
Address 138684 0
Rm No S303, Building No A15, The University of Sydney,NSW 2006
Country 138684 0
Australia
Phone 138684 0
+61 427 490 796
Fax 138684 0
Email 138684 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.