Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftobiprole Medocaril in Patients With CSF Device

Inclusion criteria

• Adult patients (> 18 years)

• Provision of informed consent prior to any study specific procedures
• Female patients of childbearing potential may be entered if pregnancy testing is negative and the patient agrees to abstain from procreational sexual intercourse or must use double-barrier contraceptive measures for the duration of the study
• Presence of an indwelling external CSF access device (ventriculostomy or lumbar drain)
• Presence of inflamed meninges as a result of documented or suspected meningitis or ventriculitis. Patients with both clinical symptoms (fever, headache, meningismus, and altered mentation) and laboratory parameters (CSF leukocytosis, defined as a CSF white blood cell count [WBC] of >103, elevated CSF protein, defined as CSF protein of >1g/l, reduced CSF glucose, defined as CSF glucose of <0.3g/l, or a positive CSF Gram stain or culture) indicative of CNS infection were deemed to have definitive bacterial meningitis/ventriculitis. Inflamed meninges were defined as the presence of >5 leukocytes/mm3 of CSF.
• Person with antibacterial treatment (including treatment for the current meningitis or ventriculitis)
• Glycemia above 3 mmol/l and below 10 mmol/l
• Natremia below 145 mmol/l
• Capnia below 45 mmHg
• No other patient included within 72 hours from D0 (treatment period) of the previous patient
• Agreement of the scientific committee

Exclusion criteria

• Hypersensitivity to MABELIO® (ceftobiprole) or to one of its excipient or another 3rd cephalosporin
• Hypersensitivity to cephalosporin
• Immediate and severe hypersensitivity to β-lactam antimicrobial other than Mabelio and other cephalosporins
• Pregnant or breast feeding women
• Renal insufficiency defined as creatinine clearance < 50 mL/min
• Patient with creatinine clearance > 150 mL/min
• Patients with conditions known or suspected to alter pharmacokinetics (i.e., burn or cystic fibrosis patients)
• Refusal to participate
• Person not affiliated to the social security
• Absolute necessity of immediate removing the device