Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, M23 9LT, United Kingdom
NCT Number: NCT05971979
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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Notify Me18 year and older
All sexes
Observational
Manchester, M23 9LT, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention
Time frame: 48 hours
Proportion of participants within timeframe for antimicrobial
Time frame: 48 hours
Mean time required for result availability
Time frame: 72 hours
Mean time required for result availability from first antimicrobial dose administration
Time frame: 24 hours
Mean time required for pre-analytical stage
Time frame: 24 hours
Mean time required for analytical stage
Time frame: 24 hours
Mean time required for post-analytical stage
Time frame: 72 hours
Proportion of patients attaining target (100% fT>4xMIC)
Time frame: 28 days
Proportion of patients alive at 28 days from enrolment
Time frame: 28 days
Number of days from ICU admission to discharge
Time frame: 28 days
Number of days from hospital admission to discharge
Manchester University NHS Foundation Trust
Other Gov
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
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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