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

NCT03317093 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-09-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03317093 on ClinicalTrials.gov