NCT03317093

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflamed Meninges
• Suspected Meningitis
• Ventriculitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-03-29
• Primary completion: 2019-10-21
• Completion: 2019-11-04
• First posted: 2017-10-23
• Last updated: 2020-09-16

Locations

1 site across 1 country: France