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NCT Number: NCT05971979

Therapeutic Drug Monitoring - Targeting IMproved Effectiveness

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wythenshawe Hospital, Manchester University NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

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

    Time frame: 48 hours

    Proportion of participants within timeframe for antimicrobial

Secondary outcomes

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

    Time frame: 48 hours

    Mean time required for result availability

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

    Time frame: 72 hours

    Mean time required for result availability from first antimicrobial dose administration

  3. Duration of pre-analytical stage

    Time frame: 24 hours

    Mean time required for pre-analytical stage

  4. Duration of analytical stage

    Time frame: 24 hours

    Mean time required for analytical stage

  5. Duration of post-analytical stage

    Time frame: 24 hours

    Mean time required for post-analytical stage

  6. Therapeutic target attainment (100% fT>4xMIC)

    Time frame: 72 hours

    Proportion of patients attaining target (100% fT>4xMIC)

  7. 28-day mortality

    Time frame: 28 days

    Proportion of patients alive at 28 days from enrolment

  8. ICU length of stay

    Time frame: 28 days

    Number of days from ICU admission to discharge

  9. Hospital length of stay

    Time frame: 28 days

    Number of days from hospital admission to discharge

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Official study 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

Acronym: TDM-TIME

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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