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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous)
时间窗: 48 hours
Proportion of participants within timeframe for antimicrobial
次要结局
- Time elapsed from peripheral blood collection to LC-MS/MS result availability(48 hours)
- Duration of analytical stage(24 hours)
- Therapeutic target attainment (100% fT>4xMIC)(72 hours)
- Hospital length of stay(28 days)
- Duration of pre-analytical stage(24 hours)
- 28-day mortality(28 days)
- ICU length of stay(28 days)
- Time elapsed from first dose of antimicrobial to LC-MS/MS result availability(72 hours)
- Duration of post-analytical stage(24 hours)