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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous) | Proportion of participants within timeframe for antimicrobial | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time elapsed from peripheral blood collection to LC-MS/MS result availability | Mean time required for result availability | 48 hours |
| Time elapsed from first dose of antimicrobial to LC-MS/MS result availability |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Hansel, MD | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wythenshawe Hospital, Manchester University NHS Foundation Trust | Manchester | M23 9LT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41459019 | Derived | 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;27(1):22-29. doi: 10.1177/17511437251404324. eCollection 2026 Feb. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 15, 2025 | |
| Reset | Jul 28, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 15, 2025 | Jul 28, 2025 |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D018805 | Sepsis |
| D001424 | Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
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Peripheral blood
Mean time required for result availability from first antimicrobial dose administration
| 72 hours |
| Duration of pre-analytical stage | Mean time required for pre-analytical stage | 24 hours |
| Duration of analytical stage | Mean time required for analytical stage | 24 hours |
| Duration of post-analytical stage | Mean time required for post-analytical stage | 24 hours |
| Therapeutic target attainment (100% fT>4xMIC) | Proportion of patients attaining target (100% fT>4xMIC) | 72 hours |
| 28-day mortality | Proportion of patients alive at 28 days from enrolment | 28 days |
| ICU length of stay | Number of days from ICU admission to discharge | 28 days |
| Hospital length of stay | Number of days from hospital admission to discharge | 28 days |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |