se of the Nutromics Sensor Device for the determination of Vancomycin concentrations and to evaluate biosensor safety.
- Conditions
- Therapeutic Drug Monitoring (TDM)Infection - Studies of infection and infectious agents
- Registration Number
- ACTRN12622000280707
- Lead Sponsor
- utromics IP Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method