Ceftobiprole's Cerebrospinal Fluid Penetration in Patients With External Ventricular Derivation (CEFTO-EVD)

Summary

Participation Requirements

Description

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, Ceftobipr...

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). CSF and blood will be spin-down at 3000 rpm for 10 minutes and then stored at -80°C. Samples will be sent all in once by courier to Laboratory of Clinical Pharmacology and Pharmacogenetics, University of Turin, Department of Medical Sciences, Amedeo di Savoia Hospital, Turin (Italy) in order to determine the serum and CSF concentration. Ceftobiprole concentrations (both in plasma/serum and CFS) will be analyzed with EMA validated LC-MS/MS methods. MDR1 gene polymorphisms will be analyzed with RT-PCR instrument, using commercial genetic probes on the blood samples.

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