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Therapeutic Drug Monitoring - Targeting IMproved Effectiveness

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05971979
Acronym
TDM-TIME
Enrollment
30
Registered
2023-08-02
Start date
2023-12-12
Completion date
2024-06-21
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Bacterial, Pneumonia, Sepsis

Keywords

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

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Manchester University NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous)48 hoursProportion of participants within timeframe for antimicrobial

Secondary

MeasureTime frameDescription
Time elapsed from first dose of antimicrobial to LC-MS/MS result availability72 hoursMean time required for result availability from first antimicrobial dose administration
Duration of pre-analytical stage24 hoursMean time required for pre-analytical stage
Duration of analytical stage24 hoursMean time required for analytical stage
Duration of post-analytical stage24 hoursMean time required for post-analytical stage
Time elapsed from peripheral blood collection to LC-MS/MS result availability48 hoursMean time required for result availability
28-day mortality28 daysProportion of patients alive at 28 days from enrolment
ICU length of stay28 daysNumber of days from ICU admission to discharge
Hospital length of stay28 daysNumber of days from hospital admission to discharge
Therapeutic target attainment (100% fT>4xMIC)72 hoursProportion of patients attaining target (100% fT\>4xMIC)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026