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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03317093
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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) 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.


Condition or disease Intervention/treatment Phase
Inflamed Meninges Suspected Meningitis Ventriculitis Drug: Ceftobiprole Medocaril Other: Blood samples and cerebrospinal fluid Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftobiprole Medocaril in Patients With CSF Device
Actual Study Start Date : March 29, 2018
Actual Primary Completion Date : October 21, 2019
Actual Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Ceftobiprole Medocaril
    1 single intravenous dose of 500 mg of Mabelio (Ceftobiprole Medocaril) perfused for 2 hours at D0
  • Other: Blood samples and cerebrospinal fluid
    Before and immediately before the end of the perfusion and then at 0.5h, 1h, 3h, 6h, 12h and 24h.


Primary Outcome Measures :
  1. Measurement of concentration of ceftobiprole in blood [ Time Frame: Before and immediately the end of the perfusion and then at 0.5, 1, 3, 6, 12 and 24 hours ]
  2. Measurement of concentration of ceftobiprole in cerebrospinal fluid [ Time Frame: Before and immediately the end of the perfusion and then at 0.5, 1, 3, 6, 12 and 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317093


Locations
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France
CHU Dijon Bourgogne
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03317093    
Other Study ID Numbers: CHAVANET BASILEA 2016
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningitis
Central Nervous System Diseases
Nervous System Diseases
Ceftobiprole
Ceftobiprole medocaril
Anti-Bacterial Agents
Anti-Infective Agents