Inflamed MeningesPhase 2BASILENCT03317093
Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftobiprole Medocaril in Patients With CSF Device
A Phase 2 study testing Ceftobiprole Medocaril and Blood samples and cerebrospinal fluid in people with Inflamed Meninges and Suspected Meningitis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflamed Meninges, Suspected Meningitis, Ventriculitis
- What is being tested?
- Ceftobiprole Medocaril and Blood samples and cerebrospinal fluid
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2018to 4 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Inflamed Meninges, Suspected Meningitis, Ventriculitis
- Being tested
- Ceftobiprole Medocaril, Blood samples and cerebrospinal fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftobiprole MedocarilDrug
1 single intravenous dose of 500 mg of Mabelio (Ceftobiprole Medocaril) perfused for 2 hours at D0
Blood samples and cerebrospinal fluidOther
Before and immediately before the end of the perfusion and then at 0.5h, 1h, 3h, 6h, 12h and 24h.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of concentration of ceftobiprole in blood
Measured: 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
Measured: Before and immediately the end of the perfusion and then at 0.5, 1, 3, 6, 12 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start29 Mar 2018
- Primary completion21 Oct 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflamed MeningesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317093
- Sponsor's protocol ID
- CHAVANET BASILEA 2016
- Acronym
- BASILE
- Status last verified
- Dec 2019
- First submitted
- 18 Oct 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftobiprole Medocaril in Patients With CSF Device
- ClinicalTrials.gov ID
- NCT03317093
- Acronym / sponsor ID
- BASILE / CHAVANET BASILEA 2016
- Conditions
- Inflamed Meninges, Suspected Meningitis, Ventriculitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult patients (> 18 years)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftobiprole Medocaril1 single intravenous dose of 500 mg of Mabelio (Ceftobiprole Medocaril) perfused for 2 hours at D0 | Drug | – |
| Blood samples and cerebrospinal fluidBefore and immediately before the end of the perfusion and then at 0.5h, 1h, 3h, 6h, 12h and 24h. | Other | – |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ceftobiprole Medocaril and Blood samples and cerebrospinal fluid in people with Inflamed Meninges and Suspected Meningitis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.