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

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.

Study Overview

• Status: Completed
• Conditions: Inflamed Meninges; Suspected Meningitis; Ventriculitis
• Intervention / Treatment: Drug: Ceftobiprole Medocaril; Other: Blood samples and cerebrospinal fluid

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • CHU Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of concentration of ceftobiprole in blood	Before and immediately the end of the perfusion and then at 0.5, 1, 3, 6, 12 and 24 hours
Measurement of concentration of ceftobiprole in cerebrospinal fluid	Before and immediately the end of the perfusion and then at 0.5, 1, 3, 6, 12 and 24 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): November 4, 2019

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Meningitis; Anti-Infective Agents; Anti-Bacterial Agents; Ceftobiprole; Ceftobiprole medocaril
• Other Study ID Numbers: CHAVANET BASILEA 2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No