Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determine the Ceftolozane-Tazobactam seric concentrations and analyse the clinic impact that could have the dose regimens used until now.
研究概览
简要总结
The aim of this study is to determine the Ceftolozane-Tazobactam Plasmatic Levels and and analyse the clinical impact that might have the dose regimens that have been used until now.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years old.
- •Hospitalised for a serious illness.
- •Treated with Ceftolozane-Tazobactam
- •Patients that signed the Informed Consent.
排除标准
- •Allergic to any component of Ceftolozane-Tazobactam.
- •Any surgical or medical evidence that according to the investigator could interfere with the pharmacodynamics of the medication: absorption, distribution, metabolism or excretion.
- •Concomitant terminal illness.
- •Unable to sign the Informed Consent.
研究组 & 干预措施
Ceftolozane-Tazobactam cohort
Patients older than 18 years old that are hospitalised in the Virgen Macarena University Hospital that are being treated with Ceftolozane-Tazobactam in empiric or targeted treatment.
干预措施: Ceftolozane/tazobactam (Drug)
结局指标
主要结局
Determine the Ceftolozane-Tazobactam seric concentrations and analyse the clinic impact that could have the dose regimens used until now.
时间窗: Up to 12 months after the antibiotic administration
Determination of the Ceftolozane-Tazobactam seric concentration by collecting 4 blood samples and measuring its antibiotic levels and if it´s achieved an adequate therapeutic efficacy assessed by the patient´s clinical and microbiological recovery. The dose regimens used until now are 1+0,5 g every 8 hours in case of intra-abdominal infection or complicated urinary infection and 2 +1 g every 8 hours in case of pneumonia or septic shock of any focus.
次要结局
- Analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with renal hyper clearance.(Up to 12 months after the antibiotic administration)
- Determine if in patients with Gram-negative bacillary bacteremia are achieved concentrations that are 100 % of the time 4 times above the minimum inhibitory concentration (MIC).(Up to 12 months after the antibiotic administration)
- Determine by a Monte Carlo simulation model the dose regimen that should be used.(Up to 12 months after the antibiotic administration)
- Describe the Ceftolozane-Tazobactam treatment´s clinical result as well as existence of adverse effects.(Up to 12 months after the antibiotic administration)
- Describe the frequency of resistance´s development during the Ceftolozane-Tazobactam treatment and, if it´s possible to evaluate if there´s a correlation with the seric levels.(Up to 12 months after the antibiotic administration)
- Determine the Ceftolozane-Tazobactam seric concentrations and analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with morbid obesity.(Up to 12 months after the antibiotic administration)
- Determine the Ceftolozane-Tazobactam seric concentrations and analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with continuous renal replacement technique.(Up to 12 months after the antibiotic administration)