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Analysis of Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment to Assess the Potential Role of Therapeutic Drug Monitoring in UK Infection Management (DATA TDM study)
Safe People
Organisation name
Imperial College London
Organisation sector
Academic Institute
Applicant name(s)
Alison Holmes
Funders/ Sponsors
Paul Arkell
DEA accredited researcher?
Unknown
Sub-licence arrangements (if any)?
No
Safe Projects
Project ID
NIBDAPC_2023_0024
Lay summary
Antimicrobials are drugs used to treat infections. They include antibiotics like penicillins (e.g. amoxicillin), cefalosporins (e.g. ceftriaxone), carbapenems (e.g. meropenem) and many others. If antimicrobials are not used correctly, for example if the wrong drug, dose, or duration of treatment is given, then the treatment may not work. This may mean that patients don't get better. It can also lead to the development of 'antimicrobial resistance', which is when bacteria or other microorganisms become 'resistant' to standard antimicrobials and are therefore more difficult to treat.Usually, patients are given standard doses of antimicrobials in a ‘one size fits all' approach, which is a standard dose of the drug. This doesn't account for potentially wide variability in response to antimicrobials between patients. Therefore, some patients may be over- or under-dosed. This study aims to observe patients receiving antimicrobial treatments for infections, measure the concentration of antimicrobials in their blood, and estimate the proportion who are dosed optimally. It will also investigate a wide variety of 'patient factors' which may be associated with sub-optimal dosing. This study will involve recruiting patients with infections at Imperial College Healthcare NHS Trust (ICHNT) and taking samples to analyse antimicrobial levels. All patients who are being treated for suspected or confirmed bacterial infections will be eligible. Groups of patients with specific diagnoses (e.g. urine tract infection) or who are being given specific antimicrobials of interest (e.g. meropenem) will be selected based on updated literature review and consensus research priority of the investigator group. Using the iCARE platform it will be possible to examine the effect of antimicrobial treatment on patient outcomes which will support the developemnt of optimised treatment guidelines.
Public benefit statement
Antimicrobials are drugs used to treat infections. They include antibiotics like penicillins (e.g. amoxicillin), cefalosporins (e.g. ceftriaxone), carbapenems (e.g. meropenem) and many others. If antimicrobials are not used correctly, for example if the wrong drug, dose, or duration of treatment is given, then the treatment may not work. This may mean that patients don't get better. It can also lead to the development of 'antimicrobial resistance', which is when bacteria or other microorganisms become 'resistant' to standard antimicrobials and are therefore more difficult to treat. Antimicrobial resistance (AMR) poses a significant global challenge. Accurate antimicrobial dosing is needed to improve patient outcomes, limit potential sides effects and reduce the development of AMR. Currently, patients are treated according to a one dose fits all approach which does not account for variations such as the infecting organism or the health of the patients. This study will identify and examine the factors that can influence the effectiveness of antimicrobial treatment to improve patient outcomes.
Request category type
Public Health Research
Other approval committees
Project start date
03/02/2026
Latest approval date
26/05/2023
Safe Data
Dataset(s) name
ICHT iCARE Data Model
Data sensitivity level
De-Personalised
Common Law Duty of Confidentiality
Not applicable
National data opt-out applied?
Not applicable
Request frequency
One-off
Release/Access date
03/02/2026
Safe Setting
Access type
TRE