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临床试验/NCT03583749
NCT03583749Unknown不适用

Pharmacokinetics and Safety of Antimicrobial Agents Administered by Subcutaneous Route in Patients AGEd Over 65 Years

University Hospital, Bordeaux5 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年8月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
5
主要终点
Plasma antibiotic concentrations

研究概览

简要总结

Elderly people are more prone to develop infection with a poorer prognosis compared to young people. Physicians may encounter difficulties regarding antimicrobial agents administration route. In fact, poor venous access and behavioral disturbance are frequent issues. The subcutaneous (SC) route may be a safe alternative, but sparse data are available in the literature. The present study aims to describe Pharmacokinetics (PK) / Pharmacodynamics (PD) characteristics of antibiotics (amoxicillin/clavulanate, ceftriaxone and piperacillin/tazobactam) subcutaneous administration in patients aged over 65.

详细描述

Antibiotic administration through subcutaneous (SC) injection is common practice in France, especially in Geriatrics as an alternative to intravenous (IV) route in case of poor venous access or delirium (Forestier et al. CMI 2015). Whereas tolerance of such a practice seems to be reasonable (Roubaud-Baudron et al. Age and Ageing 2017), sparse PK/PD data are available. Most PK/PD studies include young and healthy subjects, yet elderly patients often have multimorbidity , poly medication, renal insufficiency and cachexia which may disturb antibiotics PK/PD. Compared to intravenous (IV) route, SC route is less painful and less frequently associated with infectious or thrombotic complication. A recent study carried out in Bordeaux University Hospital comparing PK/PD data on ertapenem SC or IV administrations in patients aged over 75 showed that area under the curve (AUC) and probability to maintain free ertapenem concentration above the Minimum inhibitory concentration (MIC) during at least 40% of time (fT>MIC>40%) were not significantly different (manuscript in progress).

The investigator's hypothesis is that SC administration of amoxicillin-clavulanate, ceftriaxone and piperacillin-tazobactam has favorable pharmacokinetics and acceptable tolerance compared with IV infusion in elderly patients.

Patients receiving one of the three antibiotics by IV or SC route will be included at steady state (depending on antibiotic treatment) for several blood tests (3 or 4 depending of routes choice) and followed until 15 days after completion of antibiotic treatment in order to evaluate tolerance and efficacy of antibiotic treatment. Physicians in charge of patients will decide antibiotic prescription including administration route. The study will not influence these choices because patients will be included after antibiotic initiation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged over 65
  • To receive ceftriaxone (1g daily) or amoxicillin-clavulanate (1g/0.2g every 8h) or piperacillin-tazobactam (4g/0.5g every 8h) by SC or IV infusion (30-60minutes) at steady state (48h, 24h and 24h respectively)
  • Free, written and informed consent signed by the participant or by a proxy in case of delirium

排除标准

  • criteria for legislation (justice protection, subject participating to another research including a period of exclusion)
  • previous inclusion in this study

研究组 & 干预措施

amoxicillin-clavulanate

followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.

干预措施: Subcutaneous (SC) route for antibiotic treatment (Drug)

amoxicillin-clavulanate

followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.

干预措施: Intravenous (IV) route for antibiotic treatment (Drug)

ceftriaxone

followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.

干预措施: Subcutaneous (SC) route for antibiotic treatment (Drug)

ceftriaxone

followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.

干预措施: Intravenous (IV) route for antibiotic treatment (Drug)

piperacillin-tazobactam

followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.

干预措施: Subcutaneous (SC) route for antibiotic treatment (Drug)

piperacillin-tazobactam

followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.

干预措施: Intravenous (IV) route for antibiotic treatment (Drug)

结局指标

主要结局

Plasma antibiotic concentrations

时间窗: Day 1

Describe and compare pharmacokinetics of amoxicillin-clavulanate, ceftriaxone and piperacillin-tazobactam administered by SC and IV routes

次要结局

  • Number of hospitalisation days(Day 21)
  • Number of adverse events(Day 21)
  • Number of infection cure(Day 21)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (5)

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