Therapeutic Drug Monitoring - Targeting IMproved Effectiveness

NCT05971979 | Completed

• 1 other identifier: B01949
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia; Sepsis; Infection, Bacterial

Keywords

drug monitoring; sepsis; antibacterial agents; respiratory tract infections; antimicrobial stewardship

Outcome Measures

Primary Outcomes (1)

• Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous)

  Proportion of participants within timeframe for antimicrobial

  48 hours

Secondary Outcomes (9)

• Time elapsed from peripheral blood collection to LC-MS/MS result availability

  48 hours

• Time elapsed from first dose of antimicrobial to LC-MS/MS result availability

  72 hours

• Duration of pre-analytical stage

  24 hours

• Duration of analytical stage

  24 hours

• Duration of post-analytical stage

  24 hours

Study Arms (1)

Critically ill patients with presumed or confirmed lower respiratory tract infection

Non-interventional. Admitted to intensive care unit. Presumed or confirmed lower respiratory tract infection. Receiving either piperacillin/tazobactam or meropenem. Participants will have samples collected during an antimicrobial dose cycle.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Critically ill patients with presumed or confirmed lower respiratory tract infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria explicitly state otherwise.

You may qualify if:

• Age \> 18 years;
• Admitted to intensive care;
• Treated for presumed or confirmed lower respiratory tract infection;
• Receiving OR about to receive the first dose of intravenous antimicrobials (either meropenem of piperacillin/tazobactam);
• Valid informed consent OR enrolment through deferred consent appropriate.

You may not qualify if:

• Severe anaemia (haemoglobin level \< 70 g/L);
• Unlikely to survive 24 hours as judged by the treating physician;
• Study antimicrobial course started more than 24 hours ago.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Wythenshawe Hospital, Manchester University NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

Location

Related Publications (1)

• Hansel J, Lain J, Erhieyovwe EO, Ismayilli A, Orr J, Keevil BG, Ogungbenro K, Dark PM, Felton TW. 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. J Intensive Care Soc. 2025 Dec 24:17511437251404324. doi: 10.1177/17511437251404324. Online ahead of print.

  PMID: 41459019 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood

MeSH Terms

Conditions

Pneumonia; Sepsis; Bacterial Infections; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Study Officials

• Jan Hansel, MD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: December 12, 2023
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

GB (1)