Characterization of Ceftobiprole's Cerebrospinal Fluid Penetration in Patients With External Ventricular Derivation
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Ceftobiprole's CSF penetration
研究概览
简要总结
The Cerebrospinal fluid penetration of ceftobiprole has been studied in an animal model of meningitidis. Ceftobiprole is bactericidal, well tolerated and it has anti-biofilm activity. Altogether, these pharmacodynamics and pharmacokinetic properties of ceftobiprole are suitable for its use in case of External Ventricular Derivation(EVD)-related ventriculitis. Nowadays there are no human studies on the penetration and efficacy of ceftobiprole in the CSF. The study aims to evaluate characteristics of the CSF penetration of Ceftobiprole after intravenous administration in patients with EVD, that need for a concomitant infection this therapy (prescribed by an Infectious Diseases doctor).
详细描述
According with Inclusion and Exclusion criteria, patients with an EVD and concomitant ceftobiprole therapy will be enrolled in the study.
In particular, ceftobiprole will be prescribed by an expert infectivologist, in accordance with the MHRA guidelines.
Once the patients will be enrolled, Ceftobiprole will be administered by 2 hr i.v. infusion at the following dosage:
- normal renal function: 500mg every 8 hr
- mild renal impairment (50-80mL/min): 500mg every 8 hours
- moderate (30-49mL/min): 500mg every 12 hours
- severe (<30mL/min): 250mg every 12 hours.
The following blood and CSF sample will be drowned only during the third dose of antibiotic therapy. Blood Samples (1 mL each) will be obtained at the following time points: before and at the end of infusion of ceftobiprole, then 0.5, 1, 2, 2.5, 3 and 4 hr after drug administration (total of 8 samples), using a single venous or arterial line cannulation. CSF samples: 0.5ml will be drawned from implanted EVD with a sterile field at the same blood sample time-point, and at 6, 8 and 10 hr after the end of drug administration (11 samples total).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with External Ventricular Derivation (EVD)
- •Patients who receive ceftobiprole for any infection where Ceftobiprole could be used, as judged by an expert infectivologist
- •Patients or their relatives/parents who consent to study participation
排除标准
- •Patients with end-stage renal insufficiency
- •Patients with a BMI>30
- •Pregnancy
- •Moribund patients
- •Allergy to cephalosporine or ceftobiprole
- •Refusal to participate in the study
结局指标
主要结局
Ceftobiprole's CSF penetration
时间窗: Blood samples: before infusion, end of infusion, then 30 minutes, 1 hour, 2 hours, 2,5 hours, 3 hours, 4 hours after end of administration; CSF samples: at the same time of blood samples, then at 6 hours, 8 hours and 10 hours after end of administration
Evaluate the Cerebrospinal Fluid penetration of Ceftobiprole in patients with External Ventricular Derivation. Ceftobiprole concentrations (both in plasma/serum and CFS) will be analyzed with EMA fully validated LC-MS/MS methods.
次要结局
- Ceftobiprole's MDR1 role(The MDR1 gene will be analyzed on whole blood samples, by real-time PCR, through study completion, an average of 18 months.)
- Ceftobiprole's efficacy in CSF(The measurement is assessed through study completion, an average of 18 months.)
研究者
Piva Simone
Assistant Professor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia