Pilot phase clinical trial of a wearable, electrochemical aptamer-based patch for continuous drug concentration measurement

Abstract

As some drugs have narrow therapeutic windows and high inter-patient exposure variability, they require concentration measurements to ensure their safe and effective dosing. To improve on the current practice of sparse blood sampling, we are developing wearable 'patches' bearing electrochemical aptamer-based sensors on small, solid needles. Here we describe a pilot phase trial testing their safety and performance in six healthy human participants. The patches were found to be safe and nearly pain free, and they captured concentrations of vancomycin in the dermal interstitial fluid with 5-minute resolution over 24 hours, although, due to sensor degradation, we primarily describe data from the first 12 hours after insertion. Fitting interstitial fluid and plasma concentrations to compartmental pharmacokinetic models revealed distribution and clearance dynamics that are not detected with current sparse sampling approaches. Patches placed at different bodily sites exhibited consistent trends both within and across participants. With further testing and optimization, including real-time wireless data transmission, such patches could aid precision dosing of vancomycin and other drugs with narrow therapeutic windows. Australian New Zealand Clinical Trials Registry registration: ACTRN12622000280707 .