TDM-TIME: Therapeutic Drug Monitoring - Targeting IMproved Effectiveness

Sponsor

Jan Hansel (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05971979

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Sepsis Infection, Bacterial	Other: No intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 No intervention

Arm

Intervention/Treatment

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

No intervention

Outcome Measures

Primary Outcome Measures

Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous) [48 hours]
Proportion of participants within timeframe for antimicrobial

Secondary Outcome Measures

Time elapsed from peripheral blood collection to LC-MS/MS result availability [48 hours]
Mean time required for result availability
Time elapsed from first dose of antimicrobial to LC-MS/MS result availability [72 hours]
Mean time required for result availability from first antimicrobial dose administration
Duration of pre-analytical stage [24 hours]
Mean time required for pre-analytical stage
Duration of analytical stage [24 hours]
Mean time required for analytical stage
Duration of post-analytical stage [24 hours]
Mean time required for post-analytical stage
Therapeutic target attainment (100% fT>4xMIC) [72 hours]
Proportion of patients attaining target (100% fT>4xMIC)
28-day mortality [28 days]
Proportion of patients alive at 28 days from enrolment
ICU length of stay [28 days]
Number of days from ICU admission to discharge
Hospital length of stay [28 days]
Number of days from hospital admission to discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.