Closed-loop control of penicillin delivery
Research type
Research Study
Full title
Closed loop control of penicillin delivery integrating electrochemical biosensor technology
IRAS ID
251161
Contact name
Alison H Holmes
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 24 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 antibiotic have been 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 toxicity.
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).
A potential solution to these problems is the use of minimally invasive biosensor technology linked to closed-loop control systems. Our group have demonstrated that antibiotic biosensors (for beta-lactam antibiotics), mounted on a microneedle device and on a point-of-care capillary blood test are safe and effective at monitoring changes in antibiotic concentrations in healthy volunteers receiving penicillin antibiotics.
The next stage of this project is to link these antibiotic biosensors to a closed-loop controller and demonstrate the controllers ability to deliver antibiotics safely. This project will aim to recruit 20 healthy volunteers to receive penicillin via both conventional and closed-loop controlled methods of delivery.
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/0219
Date of REC Opinion
31 May 2019
REC opinion
Further Information Favourable Opinion