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

Primary Purpose

Inflamed Meninges, Suspected Meningitis, Ventriculitis

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Ceftobiprole Medocaril

Blood samples and cerebrospinal fluid

About this trial

This is an interventional treatment trial for Inflamed Meninges

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU Dijon Bourgogne

Outcomes

Primary Outcome Measures

Measurement of concentration of ceftobiprole in blood

Measurement of concentration of ceftobiprole in cerebrospinal fluid

Secondary Outcome Measures

Full Information

NCT ID

NCT03317093

First Posted

October 18, 2017

Last Updated

September 14, 2020

Sponsor

Centre Hospitalier Universitaire Dijon

1. Study Identification

Unique Protocol Identification Number

NCT03317093

Brief Title

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

Acronym

BASILE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

March 29, 2018 (Actual)

Primary Completion Date

October 21, 2019 (Actual)

Study Completion Date

November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflamed Meninges, Suspected Meningitis, Ventriculitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ceftobiprole Medocaril

Intervention Description

1 single intravenous dose of 500 mg of Mabelio (Ceftobiprole Medocaril) perfused for 2 hours at D0

Intervention Type

Other

Intervention Name(s)

Blood samples and cerebrospinal fluid

Intervention Description

Before and immediately before the end of the perfusion and then at 0.5h, 1h, 3h, 6h, 12h and 24h.

Primary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

CHU Dijon Bourgogne

City

Dijon

ZIP/Postal Code

21079

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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