A Phase 2 interventional study of Ceftobiprole Medocaril and Blood samples and cerebrospinal fluid in Inflamed Meninges, Suspected Meningitis and Ventriculitis, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Centre Hospitalier Universitaire Dijon · Phase 2, Interventional, and Treatment
Among 19 studies in Meningitis with a site in France — 3 open to participants now, 3 under way, none of them phase 3. Meningitis · France.
Among the 19 studies in Meningitis with a site in France, this one is the 11th largest by enrollment of the 11 interventional ones, is one of 3 that started in 2018, is one of 2 in phase 2, and was the 10th registered.
268 studies on the registry are indexed under Meningitis; 28 are open to participants now.
This study's enrollment of 5 is below the median of 260 across 185 interventional studies indexed under Meningitis.
Browse Meningitis studies →3 of the 19 studies in Meningitis with a site in France are open now, in 1 country. Each count lists the studies.
Of the 17 Meningitis studies recruiting now, 11 (65%) set no upper age limit and 6 (35%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 3 started in 2018.
Median enrollment 151 across the 11 interventional studies, 390 across the 8 observational. Of the 14 that completed or were terminated, 1 (7%) have results posted.
1 of 19 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 103 are open to participants now.
Centre Hospitalier Universitaire Dijon has 2 studies filed under Meningitis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 19 studies in Meningitis with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult patients (> 18 years)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 single intravenous dose of 500 mg of Mabelio (Ceftobiprole Medocaril) perfused for 2 hours at D0
Before and immediately before the end of the perfusion and then at 0.5h, 1h, 3h, 6h, 12h and 24h.
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
Ran from Mar 2018 to primary completion in Oct 2019, 18 months.
Of 13 phase 2 interventional studies under Meningitis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 18 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ceftobiprole medocaril
Centre Hospitalier Universitaire Dijon →