NCT05971979: TDM-TIME

Therapeutic Drug Monitoring - Targeting IMproved Effectiveness

Completed Last updated 21 November 2024

What this trial tests

trial testing No intervention in Pneumonia in 30 participants. Completed in 21 June 2024.

Timeline

12 December 2023

Primary endpoint
21 June 2024

21 June 2024

Quick facts

Lead sponsor	Manchester University NHS Foundation Trust
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	12 December 2023
Primary completion	21 June 2024
Estimated completion	21 June 2024
Sites	1 location across United Kingdom

Drugs / interventions tested

• No intervention

Conditions studied

• Pneumonia — all drugs for Pneumonia →
• Sepsis — all drugs for Sepsis →
• Infection, Bacterial — all drugs for Infection, Bacterial →

Sponsor

Manchester University NHS Foundation Trust

Who can join

18 and older, any sex, with Pneumonia or Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Severe infections can be caused by various organisms, such as bacteria or viruses, and lead to otherwise healthy people getting very unwell, sometimes needing treatment in hospital or even intensive care. For the treatment of bacterial infections to be successful, the correct antibiotics need to be given promptly. Early in the course of illness, clinicians often do not know exactly which bacteria are causing the infection. Furthermore, patients differ in terms of how their bodies process the antibiotics they are given; this means that some may get too much and others too little. This can in turn lead to some patients not being fully cured, and others coming to harm due to side effects of higher doses of these drugs.

For certain types of antibiotics, clinicians are able to measure their levels in the bloodstream, which can help guide dosing. This is called therapeutic drug monitoring, and is commonly used in clinical practice. One of the problems with therapeutic drug monitoring is that it is often not available outside of regular working hours, is costly, and most importantly, provides clinicians with useful information only after a few days of treatment have already been completed. This may be too late to treat these severely ill patients with life-threatening infections, where early and appropriate treatments matter.

The aim of our study, called TDM-TIME, is to look at how long it takes for blood samples to get from the patient to the laboratory to be measured, with the results then communicated back to clinicians. We are further looking to investigate whether steps can be taken to improve these timings, which would lead to shorter times until treatments can be improved. As our study is observational, we will not change anything about the treatment of our patients, but will only be measuring levels of antibiotics in their blood.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A prospective cohort feasibility study of real-time beta-lactam antimicrobial therapeutic drug monitoring in critically ill patients with lower respiratory infection: The TDM-TIME study.
   Hansel J, Lain J, Erhieyovwe EO, Ismayilli A, et al · · 2026 · PMID 41459019 · DOI 10.1177/17511437251404324
2. ESICM LIVES 2025
   · 2025