Pharmacokinetics of Ceftriaxone Free Fraction Administered at High for the Treatment of Serious Infections
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration [Cmax]
研究概览
简要总结
Prospective observational follow-up study for the study and modeling of the pharmacokinetics of the free fraction of ceftriaxone in patients treated with high doses of ceftriaxone (greater than or equal to 4 grams per day).
详细描述
A prospective follow-up observational study to study and model the pharmacokinetics of the ceftriaxone free fraction in patients treated with high doses of ceftriaxone (greater than or equal to 4 grams per day). it is a pilot study that has between 10 and 20 patients. This study will not condition the treatment of patients at any time.
The samples will be processed after their extraction. The concentration of the samples will be analyzed using a high-performance gilent infinity liquid chromatograph coupled to a mass spectrometer using positive or negative ionization using electrospray.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women over 55 years of age receiving treatment with high-dose ceftriaxone (minimum 4 grams / day) for any clinical indication in the study period.
- •Creatinine <1.5 mg / dL
- •The patient must have received at least 48 hours of treatment with the same previous therapeutic regimen to extraction.
- •The subject or her representative must give their verbal or written consent to participate in the study. East Consent can be revoked at any time without prejudice to the patient.
- •The consent it will be recorded in your medical record.
排除标准
- •Patients under 55 years of age.
- •Creatinine> 1.5 mg / dL
- •Patient with less than 48 hours of treatment with high-dose ceftriaxone.
- •Subjects with allergy or hypersensitivity to cephalosporins and penicillins.
- •Subjects who do not grant or withdraw their consent.
- •Patients whose concomitant treatment presents possible interactions with the study medication. The possible interactions will be evaluated by staff of the Pharmacy Service.
结局指标
主要结局
Maximum plasma concentration [Cmax]
时间窗: Up to 24 weeks.
Determine the maximum plasma concentration of ceftriaxone after the administration of high doses (equal to or greater than 4 grams / day).
次要结局
- To determine the plasma concentration of the free fraction of ceftriaxone 24 hours after the administration of the daily dose (trough level) in patients receiving doses equal to or greater than 4 grams / day.(Up to 24 weeks.)
- Determine the plasma concentration of the free fraction of ceftriaxone during 24 hours in patients receiving doses equal to or greater than 4 grams / day.(Up to 24 weeks.)
- Ceftriaxone plasma clearance.(Up to 24 weeks.)