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临床试验/NCT05950984
NCT05950984已完成不适用

An Investigation Into How Medical Device Obtained Variables Influence the Pharmacokinetic Profile of Vancomycin: a Paediatric and Adult Critical Care Feasibility Assessment at a London Tertiary-care Hospital

St George's, University of London1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月30日最近更新:
适应症

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
Objective Function Value

研究概览

简要总结

Getting the right dose of antibiotic promptly is an important part of treating infections. Unfortunately, when an infection is severe (sepsis) the body changes how it processes antibiotics. Consequently, some people with severe infection retain antibiotics for too long (risking adverse effects), whilst others excrete antibiotics too quickly (risking under-treatment).

Mathematical models can help researchers understand drug handling variability (known as pharmacokinetics) between people. These models require very accurate information about drug administration and drug blood concentration timings. Researchers usually rely on someone recording these timings, but recording errors can make models inaccurate.

We would like to understand if using data from routinely used electronic drug infusion devices (recording the exact time of administration) can improve the accuracy of pharmacokinetic models. We intend to investigate this with an antibiotic (vancomycin) that clinicians already routinely monitor blood concentrations for. Adults and children treated at St George's Hospital intensive care units will be invited to participate in the study which will last for 28-days within a 14-month period. Participants will donate a small amount of extra blood and provide researchers access to their clinical data. Blood will be taken at special times during vancomycin treatment from lines placed as part of standard treatment, minimising any pain or distress. There will be no other changes to patient's treatment.

In the future, data from this study might help change the way we dose antibiotics. The National Institute for Health and Care Research and Pharmacy Research UK are supporting the study with funding.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Day 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to either adult or paediatric intensive care unit (ICU) and receiving intravenous vancomycin (continuous or intermittent infusion only), to prevent or treat a clinical infection
  • Informed consent form signed by participant/parent/legal guardian/legal representative (as determined by age group/capacity, consent may be retrospective) or signed informed personal/nominated consultee declaration
  • Age from 1-day since birth

排除标准

  • Previous enrolment into this study
  • Treating clinician feels participant unlikely to survive beyond 48-hours from enrolment or treatment has been withdrawn for reasons of palliation
  • Absence of in-dwelling vascular access from which samples may be drawn or removal of in-dwelling access prior to retrieval of a 3rd blood sample (for assay of vancomycin concentration)
  • Non-continuous renal replacement (i.e. intermittent haemodialysis/ peritoneal dialysis)
  • Hypersensitivity or allergies to vancomycin, its excipients, or the infusion fluid
  • Treatment outside an ICU area
  • In paediatrics:
  • Required blood sampling exceeds 3% of total blood volume in a four-week period or 1% at any single time (European Medicines Agency, 2009)
  • Where there is disagreement between child consent/assent and parental/ legal guardian consent/assent

结局指标

主要结局

Objective Function Value

时间窗: Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin

Pharmacokinetic model fit determined quantitively by Objective Function Value (2.log likelihood) using vancomycin administration time data recorded by patient's bedside drug infusion devices compared to manually recorded data

次要结局

  • Participant Vancomycin Volume of Distribution(Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin)
  • Participant 24-hour AUC:MIC Ratio(Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin)
  • Participant Vancomycin Clearance(Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin)
  • Participant 24-hour Area Under the Vancomycin Concentration Time Curve (AUC)(Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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