Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftobiprole Medocaril in Patients With CSF Device (BASILE)
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|ClinicalTrials.gov Identifier: NCT03317093|
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : September 16, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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.
- 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 ]
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
|CHU Dijon Bourgogne|
|Dijon, France, 21079|