drugset / Trial / NCT03317093

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

NCT03317093

Phase 2 Completed 5 enrolled Centre Hospitalier Universitaire Dijon
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-03-29
Primary completion
2019-10-21
Completion
2019-11-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceftobiprole medocaril Small molecule 500 mg Intravenous

Indications