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

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Completed

Phase 2

Conditions

Suspected Meningitis

Inflamed Meninges

Ventriculitis

Treatments

Drug: Ceftobiprole Medocaril

Other: Blood samples and cerebrospinal fluid

Study type

Interventional

Funder types

Other

Identifiers

NCT03317093

CHAVANET BASILEA 2016

Details and patient eligibility

About

Ceftobiprole is a very active new cephalosporin on staphylococci resistant to methicillin (SEMR: Staphylococcus epidermidis Resistant to Meticillin, SAMR: Staphylococcus aureus Resistant to Meticillin) and / or vancomycin; it is also very active on pneumococci resistant to penicillin and / or 3rd generation cephalosporins. This new drug has AMM in nosocomial respiratory infections, Animal work shows the efficacy of ceftobiprole in gram negative bacillus meningeal infections.

The rationale of this study is based on the antibacterial spectrum of ceftobiprole, which would therefore be useful in the treatment of staphylococcal bacterial meningitis resistant patients (SEMR or SAMR) encountered in intensive care and / or neurosurgery and in the treatment of pneumococcal meningitis.

To validate these possibilities, it is necessary to know the concentrations of ceftobiprole in the meningeal space.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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