Status:
COMPLETED
Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftobiprole Medocaril in Patients With CSF Device
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Inflamed Meninges
Suspected Meningitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Ceftobiprole is a very active new cephalosporin on staphylococci resistant to methicillin (SEMR: Staphylococcus epidermidis Resistant to Meticillin, SAMR: Staphylococcus aureus Resistant to Meticillin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03317093
Start Date
March 29 2018
End Date
November 4 2019
Last Update
September 16 2020
Active Locations (1)
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1
CHU Dijon Bourgogne
Dijon, France, 21079