TDM-TIME v1.0
Research type
Research Study
Full title
Therapeutic Drug Monitoring – Targeting Improved Effectiveness (TDM-TIME): An observational study of turnaround time for therapeutic drug monitoring of antimicrobial agents in critically ill patients with respiratory sepsis
IRAS ID
327754
Contact name
Timothy Felton
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Research summary:
Critically ill patients with severe respiratory infections require timely treatment with antimicrobials. These need to be appropriately tailored to the patient and the micro-organism, but also given in a timely manner to achieve maximum patient benefit. Blood concentrations of commonly used antibiotics can be measured using advanced techniques such as liquid chromatography with tandem mass spectrometry. This is done as part of therapeutic drug monitoring, where the main purpose is to provide clinical teams with information on whether treatments are within the expected range.
Long turnaround times from treatment start to information from therapeutic drug monitoring being available has been noted as an ongoing challenge in previous studies. We will therefore be conducting a feasibility observational study aiming to assess the minimum time required for an antimicrobial therapeutic drug monitoring cycle in a real-world intensive care setting.
Patients admitted to the intensive care unit with a presumed respiratory infection and receiving either piperacillin/tazobactam or meropenem will be eligible. We will exclude patients with severe anaemia. Following enrolment patients will have a small amount of blood collected (up to four samples following an initial sample, up to two tablespoons altogether) from an existing indwelling arterial cannula over the period of 6-8 hours. These samples will then be processed using liquid chromatography and tandem mass spectrometry at an on-site laboratory.
The primary outcome will be availability of mass spectrometry results within two dose intervals of a given antimicrobial. Secondary outcomes will include durations of each stage (pre-analytical, analytical, post-analytical), therapeutic target attainment, hospital length of stay, intensive care unit length of stay, and 28-day mortality. We will also explore underlying patient characteristics as part of our secondary analyses.
The study will be conducted across two intensive care units at a single site. The planned enrolment period will be 6 months.
Summary of results:
Thanks to your involvement, we learned that:
In total, 67% of participants had their drug level results ready within two dosing intervals, which is a major step forward in making this type of drug monitoring faster and more practical.
The average time from taking a blood sample to getting a result was around 11 hours, which shows that real-time results are achievable in a hospital setting.
At 28 days after joining the study, 70% of participants were still alive, and half had left intensive care.
Most participants were recruited and tested during the early part of their treatment, with 40% enrolled before they received their first antibiotic dose. These findings show that testing antibiotic levels in real time is feasible.
Why this is important
Giving the right amount of antibiotics at the right time could help patients recover quicker and may even save lives. It can also help tackle antibiotic resistance, a serious problem around the world, by ensuring people are not under-treated. The insights we gained from your participation will help us design future studies and develop quicker testing methods, with the aim of improving outcomes for patients everywhere.https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT05971979%253Fterm%253Dtdm-time%2526rank%253D1%2526tab%253Dresults%2FNBTI%2FvYm_AQ%2FAQ%2Fdc29b1f8-3081-4ff9-8f69-11afbcd1fa7e%2F1%2FLjkLtmG1cO&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7Cff93162c20314a2e476608ddbe0b600c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638875678277906621%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=IYbIMhOD6hqXe9DJlUjiDYM518ntaednfUpoXW7mGQM%3D&reserved=0
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
23/YH/0203
Date of REC Opinion
29 Sep 2023
REC opinion
Further Information Favourable Opinion