Pharmacokinetics Clinical Trial
Official title:
Characterization of Ceftobiprole's Cerebrospinal Fluid Penetration in Patients With External Ventricular Derivation
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).
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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