Beta-lactam pharmacometrics in secondary care
Research type
Research Study
Full title
Defining adult beta-lactam antimicrobial pharmacokinetics across the secondary care setting
IRAS ID
207217
Contact name
Timothy M Rawson
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
2 years, 7 months, 1 days
Research summary
Antimicrobial resistance (AMR) is a leading patient health and safety issue. It can be potentiated by exposing micro-organisms to levels of antimicrobial agents that are inadequate to kill or inhibit their growth. A recent study from intensive care units in Australia has suggested that as few as 25% of the 288 patients included in the study receiving beta-lactam antimicrobials were receiving adequate doses to optimise therapeutic success of therapy, exposing patient to risks of developing AMR or toxic side effects.
This study aims to:
1.To investigate the role of therapeutic drug monitoring for optimising the use of beta-lactam agents in secondary care
2.To identify areas across secondary care where we are currently failing to optimise beta-lactam therapy
3.To explore potential pharmacodynamics indices that can be associated with treatment response across this cohort
The study is an observational pharmacokinetic study, which will not alter or change the course of clinical management for participants involved. Participants will be enrolled into the study before 120 hours of commencing antimicrobial therapy if it is deemed appropriate by their named physician. They will be consented to participate and allowed 24 hours to consider.
Researchers will collect anonymised baseline data (outlined in protocol) using routinely collected data for a range of patients in different clinical settings (e.g. ICU, haematology, general medicine, surgery, care of the elderly). The patient will undergo routine phlebotomy prior to being given their prescribed antimicrobial treatment as part of routine clinical practice. An extra 3-5mls of blood will be taken during this time that will be analysed by high performance liquid chromatography to determine the trough plasma antibiotic level of the patient.
Ranges of target achievement (trough plasma antibiotic levels greater than the micro-organisms minimum inhibitory concentration) will be compared between different clinical areas and patient types (e.g. obese). Further population pharmacokinetic analysis will also be performed.
REC name
London - Bromley Research Ethics Committee
REC reference
16/LO/2179
Date of REC Opinion
18 Jan 2017
REC opinion
Further Information Favourable Opinion