Closed loop control of antimicrobial dosing
Research type
Research Study
Full title
Closed loop control of antimicrobial dosing; utilising minimally invasive antimicrobial sensing
IRAS ID
225193
Contact name
Alison H Holmes
Contact email
Eudract number
2017-002384-17
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Evidence is emerging to demonstrate wide variations in the way that individual patients handle antibiotics during the course of their infection.
These variations lead to patients having different concentrations of the antibiotic in their system.
In patients who are critically ill (such as those with sepsis or in intensive care) lower concentrations of antibiotics are being demonstrated to put patients at increased risk of poor outcomes, such as death or development of drug resistant infections. Furthermore, if concentrations are too high patients are at risk of developing side effects.
Research has demonstrated that methods for providing personalised antibiotic dosing advice for the individual can improve patient outcomes and reduce the risks of side effects such as the development of drug resistant infections and toxic side effects.
However, many of these systems rely on sampling of blood to provide drug concentrations to be able to individualise treatment recommendations. This provides several challenges in clinical practice including: (i) difficulties with timing blood sampling; (ii) limited availability of commercial antimicrobial assays; and (iii) limited clinical data to support dose changes based on certain targets for therapy (such as trough levels or pharmacokinetic - pharmacodynamic indices).
To address these problems a potential solution is to explore the use of minimally invasive biosensors linked to closed loop control systems, which will be addressed during this research study.
This study aims to translate a antibiotic biosensor, mounted on a microneedle device that has been demonstrated as safe and effective previous in human studies in diabetes. This will be linked to a closed loop control system that has previously been demonstrated to be effective in delivery of insulin for the management of diabetes and for delivery of intravenous and inhaled anaesthetic agents.
REC name
London - Surrey Research Ethics Committee
REC reference
17/LO/1449
Date of REC Opinion
19 Sep 2017
REC opinion
Unfavourable Opinion