Minimally invasive sensing of beta-lactam antibiotics
Research type
Research Study
Full title
Microneedle sensing of beta-lactam antibiotic concentrations in human interstitial fluid
IRAS ID
236047
Contact name
Alison H Holmes
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 0 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 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).To address these problems a potential solution is to explore the use of minimally invasive biosensors. Miconeedle devices are small devices that contain tiny spikes that aim to penetrate the first layer of the skin only. This layer contains no nerve fibers or blood vessels. However, it does contain interstitial fluid, a liquid that contains many protiens and drugs that are in equilibrium with that in the patients blood, including antibiotics.
Within this study we will use an antibiotic biosensor (for beta-lactam antibiotics), mounted on microneedle device that has been demonstrated as safe and effective previous in human studies in diabetes to explore whether we can accurately monitor antibiotic concentrations.
REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/0054
Date of REC Opinion
12 Feb 2018
REC opinion
Further Information Favourable Opinion