Antibiotic Dosing in Geriatric Patients at the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Blood concentrations of amoxicillin-clavulanate.
研究概览
简要总结
In this pilot study, we will investigate whether - with the current dosing regimens, used in the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained in frail patients admitted to the geriatric department.
详细描述
In drug research studies, older people - and especially patients with a geriatric profile or frailty risk - are very frequently excluded. Moreover, drug dosing is often extrapolated from studies in younger adults with failure to consider potential differences in pharmacokinetics (PK) and pharmacodynamics (PD).
Studies on dosing of beta-lactam antibiotics in geriatric or frail patients aged 75 years or older have, to the best of our knowledge, never been performed.
In this pilot study, we will investigate whether - with the current dosing regimens, used in the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained in frail patients admitted to the geriatric department.
This monocentric, prospective, observational trial is currently ongoing at the emergency department and geriatric department of the Ghent University Hospital.
Amoxicillin/clavulanic acid 1000/200mg of piperacillin-tazobactam 4000mg or temocillin 2000mg was infused intravenously over 30 minutes using a syringe pump. The standard dosing regimes were used.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting at the emergency department and later on admitted to the geriatric department
- •Patient age 75 years or older
- •Patients with geriatric profile according to KATZ scale, G8 screening test or CIRS score.
- •Patient receiving antibiotic treatment (amoxicillin-clavulanate, piperacillin-tazobactam)
- •Intravenous access available for blood sampling. For measurement of the peak concentration an intravenous access other than the drug infusion line is required.
排除标准
- •Admission to other units than the geriatric department incl. the ICU.
- •Absence of informed consent
- •Known hypersensitivity to beta-lactam antibiotics
- •Patients who received oral amoxicillin-clavulanate prior to admission will not be included in the iv. amoxicillin-clavulanate group.
结局指标
主要结局
Blood concentrations of amoxicillin-clavulanate.
时间窗: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
Blood concentrations of piperacillin-tazobactam.
时间窗: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
Blood concentrations of temocillin.
时间窗: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
次要结局
- Achievement of pharmacodynamic targets measured by questionnaire, vital signs, blood results and side effects.(The end of individual antibiotic therapy with an average of 1 week)
- Response to antimicrobial therapy.(The end of individual antibiotic therapy with an average of 1 week)
- Measured total and unbound concentrations of beta-lactam antibiotics.(Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state))
- Clearance of betalactam antibiotics.(Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state))